Top 10 Colostomy Bag Manufacturers And Suppliers In China 2026
Table of Contents
In recent years, the global number of ostomy patients has been slowly increasing, and the demand for ostomy care products has also been gradually expanding. China has gradually emerged as a key supply chain hub for medical consumables and a major manufacturing base for colostomy bags worldwide.
Based on our past experience working with overseas distributors, international buyers typically focus on three key factors when selecting Chinese ostomy pouch suppliers: product consistency, customization capabilities, and regulatory support. They place greater emphasis on long-term partnerships.
This article will analyze representative Chinese colostomy bag manufacturers and suppliers to help you select a partner that best suits your business needs.
Comparison of the Top 10 Colostomy Bag Manufacturers in China 2026
| No. | Company | Location | Ostomy Product Range | Manufacturing Focus | Certifications | OEM/ODM | Best For |
|---|---|---|---|---|---|---|---|
| 1 | Zodelo | Suzhou, China | Colostomy, Ileostomy, Urostomy Bags | Ostomy bag R&D and manufacturing | ISO 13485, CE, FDA | Yes | Distributors, Importers, Brand Owners |
| 2 | Sitaili | China | Colostomy Bags, Ostomy Accessories | Medical consumable manufacturing | ISO 13485 | Yes | Medical distributors |
| 3 | Ostup Medical | China | One-piece and Two-piece Ostomy Bags | Ostomy product production | ISO 13485, CE | Yes | Ostomy suppliers |
| 4 | Longterm Medical | China | Ostomy Bags and Medical Consumables | Disposable medical products | ISO 13485 | Yes | Healthcare distributors |
| 5 | Hendry Medical | China | Colostomy and Urostomy Products | Ostomy care manufacturing | Medical certifications | Yes | Regional distributors |
| 6 | WEGO | Weihai, China | Medical consumables and Ostomy Products | Large-scale medical manufacturing | ISO 13485 | Limited | Hospitals and large buyers |
| 7 | Yuwell | Jiangsu, China | Medical care products | Medical device manufacturing | ISO 13485 | Limited | Healthcare distributors |
| 8 | Evergreen | China | Ostomy Bags and Accessories | Ostomy product supply | Medical compliance | Yes | Importers and wholesalers |
| 9 | Conod Medical | China | Disposable Medical Products | Medical consumables manufacturing | ISO 13485 | Yes | Medical product distributors |
| 10 | KDL | China | Medical Consumables | Medical device production | ISO 13485 | Yes | Global buyers |
How Did We Select the Top 10 Colostomy Bag Manufacturers in China?
When looking for a reliable colostomy bags Chinese supplier , focus on these six key factors: production capacity, regulatory compliance, OEM flexibility, product range, quality control, and export experience.
| Evaluation Criteria | Weight |
|---|---|
| Manufacturing Capability | 25% |
| Medical Certifications | 20% |
| OEM/ODM Capability | 20% |
| Product Portfolio | 15% |
| Quality Control System | 10% |
| Export Experience | 10% |
1. Manufacturing Capability & Production Capacity
A qualified colostomy bag supplier must have stable production capacity and be able to maintain a consistent supply in response to market changes. Key considerations include the scale of production facilities, automation capabilities, annual production capacity, supply stability, production process management, and the ability to supply a wide range of SKUs. Only manufacturers capable of ensuring a stable supply are trustworthy partners.
2. Quality Management System & Certifications
Colostomy bags are medical devices that come into direct contact with the skin and are closely related to patient safety. The quality management system is also a key criterion for selecting manufacturers. Reliable suppliers should have an ISO 13485 quality management system, CE and FDA certifications, and comprehensive product quality management processes and systems.
3. Product Range & Manufacturing Expertise
Colostomy bag manufacturers should offer a comprehensive product line and be able to develop products tailored to patients’ needs. For example: one-piece and two-piece bags; flat and contoured bags; transparent and opaque bags; specially designed colostomy bags (with carbon inserts, air vents, etc.); and colostomy accessories. A comprehensive product line can help you enhance your competitiveness in the market.
4. OEM, ODM & Private Label Capability
Customization capabilities are a key factor in selecting a supplier. A professional supplier can provide logo customization, packaging design, product specification adjustments, structural optimization, private label support, and technical documentation support. Having OEM/ODM capabilities can help you establish your own brand.
5. Quality Control & Product Testing
Products require a comprehensive testing system, including leak testing, adhesion testing, peel strength testing, pressure testing, material safety testing, and final product inspection. Every step of the testing process and every piece of data ensures patient safety.
6. Export Experience & Global Market Support
When targeting global markets, it is important to evaluate the number of countries to which a supplier exports, their experience serving international customers, their ability to provide registration documentation, their multilingual technical documentation, and their capacity for global logistics coordination. Manufacturers with experience in international markets can help you mitigate partnership risks.
7.Customer Type & Cooperation Flexibility
A reliable manufacturer of colostomy bags must not only have stable production capacity but also offer flexible partnership models tailored to the needs of different buyers. Since product testing, market evaluation, and sales validation are required in the early stages, flexible partnership models can help buyers accelerate their market development efforts.
Top 10 Colostomy Bag Manufacturers and Suppliers in China 2026
Company Overview
Zodelo is a leading Chinese manufacturer of high-end medical devices with over 25 years of industry experience. Specializing in the ostomy care field, the company integrates R&D, production, sales, and service under one roof. It operates a modern production facility spanning over 20,000 square meters and employs more than 200 people. Zodelo provides comprehensive ostomy care solutions to the global market.
Major Colostomy Pouch Products
- Colostomy Bags
- Ileostomy Bags
- Urostomy Bags
- One-piece Ostomy Systems
- Two-piece Ostomy Systems
- Ostomy Wafers / Baseplates
- Stoma accessories
Production and R&D Capabilities
Production Capacity: With a daily production capacity of over 40,000 units, we have the stable delivery capacity to handle large-volume international orders.
R&D and Patent Portfolio: We have accumulated more than 50 patented technologies, primarily focused on technical improvements in leak-proof sealing, reducing odor penetration, and enhancing the adhesion of hydrocolloid bases.
Production Environment: Equipped with dust-free cleanrooms compliant with medical device manufacturing standards, as well as automated assembly and sealing equipment.
Quality Certification and Product Testing
Quality Management System: Production operations adhere to the ISO 13485 medical device quality management system standard.
Market Access Certification: Products comply with the relevant medical device regulatory requirements of target export countries.
Biocompatibility and Skin Irritation Testing: Ensures the hydrocolloid base is hypoallergenic and non-irritating to the sensitive skin around the stoma.
Leak-Proofing and Peel Strength Testing: Rigorous pressure and durability testing is conducted on pouch seals, odor containment, and base adhesion to minimize post-sale risks.
OEM, ODM, and Private Label Services
OEM: Precision contract manufacturing according to customer-specified specifications, materials, and appearance standards.
ODM: We provide R&D and structural design support based on customers’ functional requirements.
Private Label: We support full brand customization of packaging boxes, instruction manuals, pouch printing, and outer cartons to help you quickly establish your own brand.
Who Are These Services For?
- Medical Device Importers and Wholesalers
- Private Label Manufacturers
- Purchasing Departments of Hospitals and Long-Term Care/Nursing Facilities
Company Overview
Founded in May 2003, the company is located at No. 62, Guangu Avenue, Guannan Fuxing Pharmaceutical Industrial Park, Donghu High-Tech Development Zone, Wuhan, Hubei Province. With its own international brand, Steadlive, it is one of the earliest domestic manufacturers in China to specialize in ostomy care. The company focuses on the research, development, production, and sales of ostomy care products, incontinence care products, medical dressings, and medical protective supplies.
Major Colostomy Pouch Products
Incontinence Products
Wound Dressing
Medical Protective Equipment
Production and R&D Capabilities
Core Technology: Independently developed medical-grade hydrocolloid materials and obtained invention patents, breaking foreign monopolies.
Qualifications: Designated as a National High-Tech Enterprise, holding dozens of utility model and invention patents, and equipped with automated large-scale production lines.
Quality Certification and Product Testing
International Certifications: CE, FDA registration, ISO 13485, and ISO 9001 certifications.
Quality Control: Comprehensive testing capabilities covering adhesion, air/liquid leakage prevention, and odor-blocking performance throughout the entire production process.
OEM, ODM, and Private Label Services
Customization Capabilities: Over 20 years of contract manufacturing experience; supports OEM (private label) and ODM (custom sizes, shapes, filter inserts, and packaging).
Collaboration Advantages: Rapid prototyping, flexible minimum order quantities (MOQ), and excellent value for money.
Who Are These Services For?
- Overseas Small and Medium-Sized Medical Brands
- Cross-Border E-Commerce Sellers
Company Overview
Jiangsu Huijinran Medical Devices Co., Ltd., operating under the brand name Ostup Medical.Headquartered and with its manufacturing facility in Liuhe District, Nanjing, Jiangsu Province, the company specializes in the research, development, and production of ostomy care, high-end wound care, and postoperative care supplies.
Major Colostomy Pouch Products
- One-Piece Colostomy Pouches
- Two-Piece Colostomy Pouches
- Convex/Flat-Bottom and Expandable Designs
- Ostomy Accessories and Skin Care Products
Production and R&D Capabilities
Core Technology: Possesses in-house capabilities for hydrocolloid formulation R&D and extrusion molding, resulting in high adhesion and hypoallergenic properties.
Production Facilities: We operate a Class 100,000 (ISO Class 8) cleanroom equipped with high-precision automated cutting and heat-sealing production lines.
R&D Patents: We hold multiple utility model and invention patents (such as waterproof, breathable hydrocolloid patches, anti-reflux designs, and expandable ostomy pouches).
Quality Certification and Product Testing
International Standards and Certifications: Certified under the ISO 13485 Medical Device Quality Management System, and compliant with EU CE standards as well as China’s registration/filing requirements for Class II medical devices.
Quality Control and Testing: We conduct end-to-end testing covering the entire production process, from hydrocolloid raw materials to EVOH odor-blocking membranes, with a focus on peel strength, gas/liquid barrier performance, and odor-blocking performance.
OEM, ODM, and Private Label Services
Customization Services: We offer both OEM (Original Equipment Manufacturing/Private Label) and ODM (Original Design Manufacturing—customization of structure, dimensions, and materials) models.
Flexible Customization: We support customization of aperture sizes (e.g., 15–65 mm), the color of the non-woven skin-contact layer, filter material, as well as individual color boxes and outer packaging.
Minimum Order Quantity and Response Time: Rapid prototyping and flexible minimum order quantities (MOQ) make our services ideal for brands seeking to quickly test the market and scale up operations.
Who Are These Services For?
- Overseas Medical Device Brands and Distributors
- Cross-Border E-commerce Sellers
- Domestic and international medical institutions and government procurement agencies
- Specialized retailers in wound and ostomy care:
Company Overview
Established in 2012, Zhejiang Langtian Medical is headquartered in Huzhou, Zhejiang Province, where its production base is also located, while its R&D and marketing centers are based in Hangzhou. The company operates the Langtian Medical Industrial Park—covering an area of approximately 52 mu—and specializes in the fields of functional wound dressings and ostomy care.
Major Colostomy Pouch Products
Production and R&D Capabilities
Clean Production Facility: Features a 20,000-square-meter Class 100,000 cleanroom, equipped with 16 fully automated production lines and over 50 pieces of semi-automated equipment.
R&D Capabilities and Technical Expertise: Operates a provincial-level R&D center for high-tech enterprises and holds numerous international and domestic patents.
Quality Certification and Product Testing
International System and Product Certification: ISO 13485 Quality Management System certification for medical devices issued by TÜV (Germany).
- US FDA registration and market access authorization.
- EU CE certification.
Quality Control and Testing: Comprehensive laboratory capabilities for physical and biological testing, covering hydrocolloid water absorption and tack/adhesion, airtightness and leak-proof integrity, gas barrier properties, and biocompatibility testing (skin irritation and sensitization).
OEM, ODM, and Private Label Services
OEM Contract Manufacturing: Clients can select from established pouch designs and customize packaging, printing, and specifications.
ODM Custom R&D: We collaborate with clients to develop products tailored to market needs, including custom-shaped cut-to-fit baseplates, bespoke coupling ring sizes, specialized anti-leak and odor-blocking filters, and pouch structures with specific capacities.
End-to-End Service Chain: We provide a comprehensive, closed-loop service covering the entire process—from product design, raw material selection, mold development, sterilization, and aseptic packaging to support with regulatory registration documentation for international markets.
Who Are These Services For?
- High-end private-label brand owners from Europe and the Americas
- Large-scale medical supply chain operators and distributors
- Integrated procurement providers for ostomy care and advanced wound dressings
- Suppliers for hospitals and national centralized medical procurement programs
Company Overview
Hubei Hengrui Medical Devices Co., Ltd. was established in September 2014 and is headquartered in the Yinhu Industrial Park, Xiaogan City, Hubei Province. The company is a medical device manufacturer integrating R&D, production, and sales, with core products spanning three major areas: ostomy care, incontinence care, and wound care.
Major Colostomy Pouch Products
Production and R&D Capabilities
Production and Supply Chain: The company operates standardized production facilities and a comprehensive quality control system, ensuring end-to-end oversight—from raw material procurement and processing to sealing and packaging.
Product Expansion and R&D: Beyond ostomy bags, the company possesses robust R&D and manufacturing capabilities in the field of wound care.
Quality Certification and Product Testing
International Quality System: Certified under the ISO 13485 quality management system for medical devices.
Market Access Certification: Products hold CE certification, qualifying them for entry into the European Union and international markets that recognize the CE system.
Quality Control Testing: Batch-specific factory inspections are conducted for product adhesion, leak resistance, hydrocolloid solubility, and sterility/hygiene standards.
OEM, ODM, and Private Label Services
Customization Capabilities: Supports flexible OEM and ODM partnership models.
Private Labeling: Offers customization of outer packaging, brand logo printing, and adjustments to chassis dimensions and formulations to meet the specific requirements of overseas buyers or brands.
Who Are These Services For?
- Cross-border e-commerce and B2C sellers
- Overseas medical device importers and distributors
- Domestic and international clinics and home care retailers
Company Overview
Founded in 1988 and headquartered in Weihai, Shandong Province, Weigao Group is a leading global giant in the comprehensive medical device and pharmaceutical consumables sectors. With a workforce of over 30,000 employees, the Group’s business spans multiple segments—including medical devices, pharmaceuticals, orthopedics, blood purification, cardiac and spinal surgery, and medical polymer consumables—and it ranks among China’s Top 500 Enterprises.
Major Colostomy Pouch Products
- One-piece open/closed pouches
- Two-piece hook-and-loop/snap-on ostomy pouches
- Ileostomy and urinary ostomy pouches
- Includes ostomy skin care powder
- Skin protection film
- Ostomy leak-proof adhesive ring
- Ostomy support belt
Production and R&D Capabilities
R&D Capabilities: The company operates a state-level enterprise technology center and a postdoctoral research workstation; its R&D investment consistently ranks among the highest in the domestic medical device industry, and it holds thousands of patents.
High-Precision Production Lines: Equipped with Class 10,000 and Class 100,000 cleanrooms and utilizing fully automated, intelligent production equipment for ostomy bags and polymer materials, the company boasts exceptional production capacity and consistent quality.
Quality Certification and Product Testing
International System Certification: Certified under ISO 9001 and ISO 13485 .
Global Market Access: Key products have obtained NMPAand CE certifications, as well as FDA registration.
Quality Control Standards: Strict pre-shipment inspections conducted in accordance with pharmaceutical-grade standards, covering biocompatibility, subcutaneous irritation, high airtightness/leak-proof integrity, and adhesive durability.
OEM, ODM, and Private Label Services
Supply Chain and Contract Manufacturing Capabilities: WEGO Medical possesses a mature OEM/ODM business system, providing high-volume, precision customization services to numerous renowned global medical brands and multinational procurement groups.
Private Labeling: We support end-to-end customization—spanning polymer material R&D, base material die-cutting, and bag design through to outer packaging and printing—backed by robust capabilities in regulatory compliance and supply chain fulfillment.
Who Are These Services For?
- Large-scale medical device distributors and public/private hospital purchasers
- International multinational medical brands and brand owners
- Large-scale pharmacy chains and regional distributors
Company Overview
Founded in 1998 and headquartered in Danyang, Jiangsu, Yuwell is one of China’s undisputed leaders in the fields of home medical devices and clinical medical equipment. Ostomy care and surgical consumables serve as key complements to Yuwell’s “home medical devices and medical consumables” business segment. The company’s ostomy bag product line commands strong brand appeal in both the mass consumer market and e-commerce channels.
Major Colostomy Pouch Products
- One-piece ostomy bag
- Two-piece ostomy bag
- Closed-end bag
- Urostomy bag
Production and R&D Capabilities
R&D: Yuwell operates a national-level enterprise technology center and global R&D centers across locations such as Shanghai, Nanjing, and Danyang, demonstrating strong capabilities in industrial design and engineering implementation.
Smart Manufacturing and Production Capacity: The company owns a modern medical device industrial park spanning hundreds of *mu* (tens of hectares), featuring high-standard cleanrooms and automated sealing, cutting, and injection molding production lines, ensuring excellent quality control and supply chain stability.
Quality Certification and Product Testing
Domestic Compliance: Holds a medical device registration certificate issued by the National Medical Products Administration (NMPA) of China.
International System Certifications: Certified under ISO 13485 (medical device quality management system) and CE standards; select key consumables are qualified for export.
Rigorous Testing: Subjected to stringent laboratory testing covering bag tensile strength, airtightness, leak resistance, and odor control, as well as the biocompatibility and skin irritation properties of the hydrocolloid material.
OEM, ODM, and Private Label Services
Brand Strategy: Yuwell focuses primarily on promoting and selling its own brand, commanding a significant brand premium and high levels of user trust.
Customized Partnerships: Yuwell also has the capability to fulfill OEM/ODM orders for large-scale B2B clients, specific overseas markets, or major retail chains.
Who Are These Services For?
- Domestic OTC pharmacy chains and medical device retail stores
- Sellers on e-commerce and comprehensive healthcare platforms
- Home care, rehabilitation, and elderly care facilities
- Wholesalers targeting specific overseas markets
Company Overview
Located in Wujiang District, Suzhou City, Jiangsu Province, Hengqing Medical is a traditional export-oriented manufacturer of medical consumables, specializing in the R&D and production of medical hygiene materials, surgical dressings, and products for ostomy and drainage care. Leveraging the well-developed medical consumables industry cluster in the Yangtze River Delta, the company exports a significant volume of its products to regions including Europe, Southeast Asia, South America, and the Middle East.
Major Colostomy Pouch Products
- One-piece ostomy bag
- Two-piece ostomy bag
- Drainable bag
- Closed-end bag
- Urostomy bag
Production and R&D Capabilities
Production Base: Features standard cleanroom production facilities and fully automated production lines for injection molding, sealing and cutting, and composite bag manufacturing.
Manufacturing Advantages: Leveraging Wujiang District’s mature supply chain for textiles and polymer materials, the company achieves exceptional cost-efficiency and stable production capacity in core manufacturing processes, including non-woven fabric lamination, adhesive tape coating, and heat-sealing/cutting of bag bodies.
Quality Certification and Product Testing
System certification: complies with the medical device production quality management specifications and passed the ISO 13485 medical device quality management system certification.
Export qualifications: The main products have obtained EU CE certification and have the ability to enter overseas target markets in compliance with regulations.
Factory testing: Strict batch inspections are conducted on key indicators such as product sealing strength, leakage resistance, colloid adhesion and air tightness.
OEM, ODM, and Private Label Services
Core Business Model: As a typical export-oriented manufacturer, the company primarily operates through OEM and private-label services.
Customization Services: The company supports customer customization regarding bag dimensions, base shapes, outer packaging designs, brand logo printing, and various specifications for buckles or sealing clips, offering relatively flexible minimum order quantities (MOQs).
Who Are These Services For?
Small and medium-sized overseas medical device importers and brand owners
Cross-border e-commerce sellers
Markets in developing countries
Company Overview
Established in 2003 and headquartered in Changshu, Jiangsu, Jiangsu Kangnuo Medical Devices Co., Ltd. is a prominent domestic enterprise specializing in the R&D and manufacturing of disposable medical consumables and medical devices. The company operates production facilities spanning over 160,000 square meters—including tens of thousands of square meters of high-standard cleanrooms (Class 100,000 or higher)—and employs a workforce of 800 to over 1,000 people.
Major Colostomy Pouch Products
- One-piece ostomy bag
- Two-piece ostomy bag
- Urostomy bag
Production and R&D Capabilities
R&D Capabilities: We maintain a team of over 100 professionals dedicated to R&D, technical operations, and quality assurance. We operate a precision mold design and development center and are equipped with CNC precision engraving machines, 3D printers, and dozens of precision injection molding machines.
Full-Chain Manufacturing: Our production capabilities encompass the entire process—from component injection molding, thermoforming, and bag assembly to sealing, packaging, and sterilization.
Quality Certification and Product Testing
Systems and Certifications: Certified under the ISO 13485 quality management system for medical devices; products hold the EU CE mark, and select products have completed US FDA registration/listing.
Testing and Quality Control: Capable of independently conducting burst pressure testing for ostomy bags, hydrocolloid adhesion testing, assessments of leakage and odor-blocking performance, and biocompatibility evaluations.
OEM, ODM, and Private Label Services
OEM / Private Label: We offer established, ready-made product structures and support customer-specific private labeling, outer packaging design, and the printing of multilingual instructions.
ODM In-Depth Customization: We provide comprehensive collaborative R&D and mass production services tailored to specific market needs or clinical feedback—covering everything from product capacity, material barrier grades, and hydrocolloid formulations to structural mold development.
Who Are These Services For?
Overseas medical device brands and contract manufacturers
Multinational importers and wholesalers of medical consumables
Hospitals and nursing institutions sourcing for their own private-label brands
Company Overview
Established in 1987, Shanghai Kindly Enterprise Development Group Co., Ltd. is a leading publicly listed company in China specializing in medical puncture instruments and polymer medical consumables. Headquartered in Shanghai, the company operates multiple production bases and subsidiaries. Leveraging decades of manufacturing expertise, KDL’s product portfolio encompasses medical needles, infusion devices, interventional instruments, and nursing consumables.
Major Colostomy Pouch Products
- One Piece Ostomy Bag
- Two-piece ostomy bag
- One Piece Urostomy Bag
- Two Piece Urostomy Bag
- Skin Barriers & Accessories
Production and R&D Capabilities
R&D and Technical Expertise: Recognized as a National High-Tech Enterprise, KDL boasts a substantial R&D and engineering team with strong independent innovation capabilities in medical polymer materials, precision mold design, and automated assembly processes.
Large-Scale Automated Production: Operates high-standard Class 100,000 cleanrooms equipped with extensive automated machinery for injection molding, heat sealing, and packaging.
Quality Certification and Product Testing
Systems and Certifications: The Group has obtained ISO 13485 certification for its medical device quality management system; its core products hold EU CE certification and have completed registration and market listing with the US FDA.
Rigorous Testing: Equipped with comprehensive physical, chemical, and biological laboratories, the Group conducts stringent testing on ostomy bag products, including burst pressure tests, baseplate adhesion (holding power and initial tack) tests, gas barrier property inspections, and biocompatibility assessments.
OEM, ODM, and Private Label Services
OEM / Private Label: With massive production capacity and standardized production lines, we provide mature private-label services for hydrocolloid patch products, supporting multilingual customization of outer packaging, labels, and instruction manuals.
ODM / Joint Development: We offer in-depth customization services—ranging from conceptual design, hydrocolloid formula fine-tuning, and custom barrier film specifications to injection mold development—helping brands achieve competitive differentiation.
Who Are These Services For?
International medical device brands and contract manufacturers
Major importers and distributors of medical consumables
Owner of proprietary brands for ostomy and nursing care products
Which Chinese Colostomy Bag Manufacturer Is Best for Your Purchasing Needs?
1.Zodelo
Core Positioning:
A professional OEM/ODM ostomy pouch manufacturer specializing in the R&D and production of ostomy care products, with core technologies in hydrocolloid base development and leak-proof sealing.
Target Market:
Private label and OEM/ODM buyers in Europe, the U.S., and mid-to-high-end markets; overseas medical device importers seeking high cost-effectiveness, stable delivery, and a complete range of ostomy care products (such as leak-proof sealing rings and skin care powders).
2.Sitaili
Core Positioning:
A domestic manufacturer specializing in ostomy and wound care, with extensive experience in the research, development, and production of hydrocolloid and ostomy pouch products.
Target Audience:
Domestic and international distributors seeking high-quality, cost-effective ostomy care products, as well as regional medical institutions with high requirements for the gentleness and leak-proof performance of hydrocolloid bases.
3.Ostup Medical
Core Positioning:
A professional OEM/ODM manufacturer specializing in ostomy care, with the capability to customize multi-line ostomy pouches and accessories, as well as the necessary export compliance certifications.
Target Audience:
Cross-border medical device buyers seeking rapid expansion into overseas markets, requiring flexible OEM mass production solutions, and a one-stop ostomy product portfolio.
4.Longterm Medical
Core Positioning:
A specialized OEM/ODM medical device manufacturer focused on wound care, ostomy care, and infection control; the company possesses capabilities for the customized production of a full range of ostomy bags and accessories, and maintains a comprehensive system of international export compliance certifications.
Target Audience:
Seeking multinational medical device purchasers, brand owners, cross-border e-commerce brands, and large-scale medical channel distributors looking to rapidly penetrate and expand into overseas markets.
5.Hendry Medical
Core Positioning:
A medical device manufacturer specializing in ostomy care and advanced wound dressings. The company possesses R&D and production capabilities for a comprehensive product range—including one-piece and two-piece ostomy bags, urostomy bags, and accessories such as leak-proof pastes and barrier films—and holds the necessary medical system certifications and compliance credentials for international market export.
Target Markets:
Overseas distributors, medical supply importers, and cross-border e-commerce buyers focusing on cost-effective ostomy care products, as well as OEM/ODM partners seeking suppliers with fundamental mass-production capabilities and the flexibility to accommodate customization.
6.Weigao Group
Core Positioning:
A large-scale, comprehensive medical manufacturing group and China’s leading provider of medical polymer consumables, with massive-scale, high-volume automated production capabilities and a deep-rooted distribution network.
Target Markets:
Large-scale domestic and international government procurement tenders, high-volume centralized procurement of medical insurance and hospital consumables, and centralized purchasers seeking exceptional value for money and supply chain stability.
7.Yuyue
Core Positioning:
A leading publicly traded company in China’s home medical devices and rehabilitation care sector, with strong brand influence and a comprehensive network of online and offline retail channels.
Target Audience:
OTC pharmacy chains, home medical device retailers, and sellers on major e-commerce platforms; ideal for home and OTC buyers seeking brand recognition and high value for money.
8.Evergreen
Core Positioning:
An enterprise integrating the manufacturing and export of medical consumables and nursing products, with a product portfolio spanning ostomy bags, drainage bags, wound dressings, and basic disposable medical consumables; the company possesses large-scale production capabilities for basic ostomy care products and holds the necessary qualifications for overseas export.
Target Customers:
Comprehensive medical supply importers and overseas distributors of small-to-medium-sized medical devices seeking one-stop sourcing for a diverse range of medical consumables, as well as OEM clients who prioritize manufacturing quality and supply chain stability.
9.Conod Medical
Core Positioning:
A comprehensive manufacturer specializing in urological drainage, negative-pressure drainage, nursing consumables, and polymer-based medical devices. Leveraging robust in-house capabilities for injection molding and mold development, the company possesses the capacity for both mass production and customization of high-precision products such as urine bags, catheters, and drainage kits.
Target Audience:
An importer of overseas medical devices—specializing in urology and clinical drainage consumables—and a distributor serving large hospital networks and medical/surgical kit assemblers, as well as a partner for international buyers seeking mature injection mold R&D and large-scale OEM/ODM manufacturing services.
10.Kangnuo
Core Positioning:
A leading contract manufacturer (OEM/ODM) of ostomy care products and medical protective equipment in Jiangsu, possessing modern 100,000-class cleanrooms, advanced automated production lines, and an integrated supply chain for specialized stoma bags and skin barrier accessories.
Target Audience:
International ostomy care brand owners, large healthcare distributors, and hospital supply vendors seeking a one-stop, highly scalable manufacturing partner for custom ostomy products and medical supplies.
What Types of Colostomy Bags Can Chinese Manufacturers Supply?
By System Structure: One-Piece vs. Two-Piece Systems
One-Piece Ostomy Bags:
Features: The baseplate and bag are integrated into a single unit; they are lightweight, discreet, and easy to apply.
Advantages of the Chinese Supply Chain: Offers high-volume automated production with significant cost advantages, making them suitable for bulk hospital purchases and OTC retail.
Two-Piece Ostomy Bags:
Features: The baseplate and pouch are separate, connected via mechanical clips or adhesive strips. Replacing the pouch does not damage the skin.
Advantages of the Chinese Supply Chain: Leading Chinese manufacturers have mastered high-seal, leak-proof clip technology and flexible hydrocolloid bonding processes.
By Closure & Drainage Mechanics
Drainable / Open-End Pouches:
Equipped with Velcro, an integrated closure, or tail clips.
Closed-End Pouches:
Single-use, with a built-in carbon filter; suitable for social settings and for stool from a mature colostomy.
Urostomy Pouches:
Equipped with an anti-reflux valve and a soft drainage valve; can be connected to an external drainage bag.
By Barrier Shape
Flat Skin Barriers: General-purpose products designed for flat skin.
Convex / Flexible Convex Barriers: Designed specifically for concave or flat stomas; factories in China with die-cutting and silicone/hydrocolloid composite compression capabilities can provide custom convex profiles.
By Special Design & Customization
Activated Charcoal Filter: Features leak protection, efficient venting, and odor elimination.
Non-Woven Split Window: Made of waterproof, medical-grade non-woven fabric, with an observation window to facilitate examination by medical staff.
Skin-Friendly Hydrocolloid Formulas: Supports customization of acid- and alkali-resistant (pH 3–12), gentle removal, and leak-resistant formulations.
What Are the Advantages of Sourcing Colostomy Bags From China?
1. Cost-Effectiveness and a Complete Industrial Chain
From medical-grade hydrocolloid raw materials, high-barrier EVOH films, and activated carbon filters, to sealing and assembly in cleanrooms, and printing of outer packaging boxes, China boasts a complete industrial cluster.
Automated production lines have significantly reduced unit production costs, enabling you to secure factory-gate prices that are 30%–50% lower than those of products manufactured in Europe or North America, thereby achieving higher profits.
2. Specialized R&D in Pad Technology
Our Chinese manufacturing facility has developed a high-end hydrocolloid pad featuring high absorption capacity, low allergenicity, gentle removal, and long-lasting leak protection.
We have established a mature supply chain for flexible convex pads, anti-bloating activated carbon filters, anti-reflux valves, and microporous nonwoven fabric viewing windows to meet diverse clinical needs.
3. Compliance with International Quality Certification and Regulatory Standards
China’s leading ostomy pouch exporters strictly adhere to the ISO 13485 Medical Device Quality Management System and have obtained EU CE certification and U.S. FDA registration.
The products have passed skin irritation, sensitization, and cytotoxicity tests in accordance with the ISO 10993 standard and come with comprehensive test reports on airtightness and peel strength, thereby reducing your compliance and after-sales risks.
4. Flexible OEM/ODM & Private Label Capabilitie
We offer comprehensive private label services, ranging from mold development for the base to modifications to the bag shape, nonwoven fabric color selection, and activated carbon valve configurations, all the way to the design of color boxes, instruction manuals, and barcodes.
Suppliers in China generally offer flexible minimum order quantities and faster prototyping cycles.
5. Massive Production Capacity and Reliable Global Logistics
Our large-scale factories have a daily production capacity ranging from tens of thousands to hundreds of thousands of units, enabling us to easily meet the demands of large-volume global medical device tenders and urgent order renewals.
We are thoroughly familiar with global medical device customs clearance procedures and ocean/air freight logistics standards, ensuring that goods are delivered safely and on time to major ports worldwide.
How to Choose a Reliable Colostomy Bag Manufacturer in China?
Step 1: Verify Essential Medical Certifications and Compliance
List of Essential Certifications:
- ISO 13485: Medical Device Quality Management System (basic requirement).
- CE (MDR): Required for compliance to enter the EU and CE-recognized markets.
- FDA 510(k): Required registration for entry into the U.S. or North American markets.
Step 2: Evaluate Core Technology & Material Quality
Hydrocolloid Formulation: Evaluate whether the base layer exhibits low allergenicity, gentle removal properties, and strong resistance to leakage.
Key Component Quality: Verify the use of medical-grade, high-barrier EVOH film, activated carbon vent filters, and nonwoven fabric.
Step 3: Assess OEM/ODM & Private Label Flexibility
Level of Customization Support: Can the factory customize the bag shape, mold convex bases, change the non-woven fabric color, and design the outer packaging according to specific requirements?
MOQ and Samples: Reliable factories typically offer flexible trial samples and phased minimum order quantities (MOQs) to reduce the risk of capital tied up for new brands.
Step 4: Audit Quality Control & Testing Standards
Laboratory Testing Items: Inquire whether the factory is equipped with an in-house testing laboratory, focusing on the following three core tests:
- Air Tightness/Leak Test
- Chassis Peel Strength Test
- Odor Barrier and Filter Exhaust Efficiency Test
Step 5: Conduct Factory Audits & Capacity Checks
Facility Environment: Verify whether the factory has cleanrooms that meet medical standards and automated production equipment.
Third-Party Factory Audits: Support on-site audits conducted by third-party organizations such as SGS, TÜV, and BV; this is a highly effective method for identifying high-quality, large-scale manufacturers.
What Quality Factors Should You Check When Buying Colostomy Bags?
- Skin Biocompatibility: The base must pass standard skin irritation, sensitization, and cytotoxicity tests to minimize the risk of skin irritation and allergic reactions.
- Balanced Adhesion & Gentle Removal: A good hydrocolloid should provide rapid initial adhesion, adhere tightly to the skin at body temperature, and resist erosion by excreta, while not damaging the skin around the stoma when removed.
- Multi-Layer EVOH Film: Verify that the pouch utilizes a multi-layer composite barrier film to ensure extremely low gas permeability and reduce the transmission of odor molecules.
- Noise Reduction & Flexibility: The pouch film should be flexible and quiet, producing no noticeable “clicking” noise during friction or contact with clothing, thereby ensuring privacy.
- Gas Flow & Odor Neutralization: The filter must allow gas to escape smoothly from the pouch to prevent swelling, while utilizing activated carbon granules to absorb gas molecules.
- Liquid Resistance: Verify that the filter panel features a waterproof, breathable membrane to minimize the risk of waste inside the bag wetting or clogging the filter.
- Seam Strength & Pressure Resistance: The heat-sealed seams along the bag’s edges must undergo rigorous pressure and tensile strength tests to prevent the bag from bursting when bending over, being squeezed, or expanding.
What Tests Should a Colostomy Bag Manufacturer Perform?
A:Biocompatibility and Skin Safety Testing
Since the backing and the skin-contact nonwoven fabric come into direct contact with the patient’s sensitive skin, they must undergo the following three fundamental biological evaluations:
- Cytotoxicity Test (ISO 10993-5): Ensures that the materials are non-cytotoxic.
- Skin Irritation Test (ISO 10993-10): Verifies that prolonged application does not cause redness or inflammation.
- Sensitization Test (ISO 10993-10): Confirms the absence of potential allergens.
B:Physical & Mechanical Strength Testing
- Burst & Static Pressure Resistance: The bag is filled with water or air to a specified pressure to test the pressure resistance limits of the seals and seams, preventing the bag from bursting when the patient bends over or bends their body.
- Tensile & Heat-Seal Seam Strength: Measures the heat-seal peel strength of the bag’s edges, clips/loops, and the Velcro fastener at the tail end to ensure they do not tear under stress.
- Coupling Retention Force: For two-piece systems, this test evaluates the holding force between the chassis and the bag’s clasp, as well as the durability of repeated coupling and uncoupling, to prevent detachment.
C:Barrier & Odor Integrity Testing
- Odor Transmission Testing: A substance with a pungent odor (such as standard reagents like onions or sulfides) is sealed inside a pouch and placed in a sealed container maintained at a constant temperature and humidity to test the gas permeability of the EVOH multilayer barrier film over a period of 4–24 hours.
- 100% Online Air-Leakage Testing: During the packaging process on automated production lines, each pouch undergoes airtightness testing via barcode-scanned spot checks or 100% inspection using either positive or negative pressure differential detection methods.
D: Hydrocolloid Barrier Performance Testing
- Peel Adhesion & Tackiness: Evaluates the initial adhesion and peel strength of hydrocolloids at body temperature to ensure they “stick firmly yet peel off easily.”
- Wet Integrity & Absorption Rate: Simulates an environment of wound exudate or sweat to test the hydrocolloid’s expansion rate and resistance to dissolution and erosion after absorbing moisture from exudate.
What Certifications Are Required When Importing Colostomy Bags From China?
1.Universal Quality Management System: ISO 13485
ISO 13485:2016 is the foundational quality management system certification for medical device manufacturers.
This certification demonstrates that the manufacturer has established comprehensive quality management processes covering raw material procurement, production control, product inspection, packaging, and traceability management.
2.European Union Market Access: CE Marking under MDR EU MDR
Key Requirements:
- Technical Documentation: A complete biocompatibility report and clinical evaluation.
- European Authorized Representative: The Chinese manufacturing facility must designate a compliant European Authorized Representative.
- UDI: The packaging must bear a unique device identifier (UDI).
3.United States Market Access: FDA Registration
Suppliers of ostomy pouches entering the U.S. market must complete the following:
- FDA Establishment Registration
- Device Listing
Depending on the product classification and functional design, some products may require FDA 510(k) clearance.
4.Region-Specific Compliance Certifications
- UKCA: Products exported to the UK domestic market must bear the UKCA mark and have a UK authorized representative.
- Health Canada Licensing: A medical device establishment license or product registration is required, depending on the classification.
- TGA Clearance: Registration with the Australian TGA for medical devices.
- Free Sale Certificate: Issued by the China Council for the Promotion of International Trade (CCPIT) or the China National Medical Products Administration (NMPA), this certificate is commonly used for export clearance and government tenders in the Middle East, Southeast Asia, and Latin America.
What Can Be Customized for Colostomy Bags?
- Flat vs. Convex: Customize standard flat, slightly convex, or deeply convex base molds to fit recessed or flat stomas.
- Cutting Range: Custom pre-cut apertures or a large-size universal cutting range.
- System Type: Supports customization of specifications for 1-piece and 2-piece systems.
- Drainable: Optional integrated hook-and-loop fasteners, rigid tail clips, or specialized drainage valves.
- Closed-End: Customization of single-use pouches.
- Fabric Types: Choose from hydrophilic ultra-soft nonwoven fabric, waterproof quick-dry nonwoven fabric, or antimicrobial perforated fabric to reduce skin friction, noise, and the likelihood of redness.
- Color & Design:Customization options include neutral gray, standard skin tone, or non-woven fabric-free bags.
- Box & Outer Carton Design: Full-color printing of brand logos, product barcodes, multilingual instructions, and brand-exclusive packaging boxes.
How to Verify a Colostomy Bag Supplier in China?
Distinguish Real Manufacturers from Trading Companies
- Check Business License: The business license must include “production” or “manufacturing.”
- Verify Manufacturing Address: Check whether the factory’s production address matches the “Factory Address” listed on the ISO 13485 certificate, CE certificate, and FDA registration.
- Video Audit or Live Factory Tour: Request that the supplier conduct a live video call to directly view their cleanroom, automated sealing production line, and R&D laboratory.
Cross-Check Regulatory Database Compliance
- FDA Registration Search: Search the FDA database using a supplier’s 10-digit Registration Number or FEIN to verify their listed products.
- EU MDR & Notified Body Audit: Confirm whether the CE certificate was issued by an EU-authorized Notified Body.
- ISO 13485 Authenticity: Use IAF CertSearch to verify that the ISO 13485 certificate is active.
Request Product Test Reports & COA
- Biocompatibility Reports: Third-party test reports compliant with ISO 10993 are required.
- Batch COA: A COA report covering airtightness testing, peel strength, and activated carbon desorption efficiency must be provided for each batch of shipped products.
Perform Physical Sample Testing
- Adhesion and Residue Testing: Apply the hydrogel to glass or skin to test its initial tack, ease of removal, and whether any adhesive residue remains.
- Leak and Burst Resistance Testing: Inflate the bag with air or fill it with water, seal the opening, and apply pressure to check the strength of the heat-sealed edges.
- Odor and Filter Testing: Place odorous substances inside to test the odor-blocking barrier properties of the EVOH film, as well as the breathability and resistance to clogging of the activated carbon filter.
What Information Should You Prepare Before Requesting a Colostomy Bag Quotation?
System & Closure Type: One-piece or two-piece; open-end, closed-end, or urinary-type
Skin Barrier & Convexity: Flat base or convex base
Key Features: Is a built-in activated carbon vent filter required?
Pouch Film Requirements: Fully transparent (Clear), skin-tone (Beige), or with a non-woven fabric viewing window (Split Window)?
Destination Country: Inform the supplier of the country or region to which the goods will be exported.
Mandatory Certifications: Are CE, FDA, or ISO 13485 certifications required?
Estimated Order Volume: Clearly specify the quantity of samples for the initial order as well as the estimated annual or quarterly purchase volume.
MOQ Expectations: If small-batch trial orders are needed, specify this in advance to help the supplier evaluate flexible production scheduling options.
Target Delivery Date: Specify the sample lead time and the delivery date for the production order.
Packaging Format: Number of units per box (e.g., 10 per box, 30 per box).
Branding Scope: Do you need custom color boxes, logo printing on outer cartons, and multilingual instruction manuals?
Incoterms: Specify the quotation type, such as FOB, CIF, or DDP.
Shipping Method: Express shipping for samples, air freight, or full container load (FCL) or less than container load (LCL) by sea.
Why Choose Zodelo as Your Colostomy Bag Manufacturer?
Zodelo has specialized in the research, development, and manufacturing of ostomy care products for 25 years. Its product lineup includes one-piece and two-piece systems, as well as colostomy, ileostomy, and urostomy pouches. More than 150 professional R&D staff members continuously optimize hydrocolloid bases, leak-proof structures, and pouch designs to meet the product needs of various markets.
The company operates in accordance with medical device quality management system requirements and implements strict controls in raw material inspection, production process control, and finished product testing. It also provides CE MDR compliance support, FDA registration support, and ISO 13485 certification documentation to help global customers meet various market access requirements.
For overseas distributors, importers, and brand owners, Zodelo offers flexible OEM/ODM and private-label customization services, covering product structure adjustments, hydrocolloid base solutions, pouch film selection, packaging design, and brand production support, helping clients develop ostomy care products that meet local market needs.
FAQs About Colostomy Bag Manufacturers in China 2026
How Do Chinese Colostomy Bag Manufacturers Ensure Stable Supply?
Stable supply typically relies on robust supply chain management, raw material inventories, multiple production lines, and rigorous production scheduling to ensure the timely delivery of long-term orders from distributors.
Can Chinese Manufacturers Provide OEM and Private Label Services?
Yes. Chinese medical device manufacturers widely support OEM and ODM services, offering the flexibility to adjust product specifications, dimensions, and branding according to client requirements, while providing end-to-end services ranging from R&D and design to production and delivery.
Can I Get Colostomy Bag Samples Before Ordering?
Yes. Whether through B2B platforms or by contacting manufacturers directly, you can usually request free or paid samples for testing to evaluate the product’s material, seal, and comfort.
What Is the Minimum Order Quantity (MOQ) for Colostomy Bags?
The Minimum Order Quantity (MOQ) for Chinese colostomy bag manufacturers depends on the product type, customization requirements, and order volume. Standard products allow for more flexible MOQs, whereas OEM/ODM customized products—which involve adjustments to packaging, specifications, and production—typically require higher MOQs. Partnership plans tailored to specific needs are available.
Do Chinese Colostomy Bag Manufacturers Support Hospital Tender Projects?
Supported. Legitimate domestic manufacturers hold a “Medical Device Manufacturing License” and Class II/III medical device registration certificates, meeting the qualification requirements for public hospital tenders in China.
Which Countries Can Chinese Colostomy Bag Manufacturers Export To?
Chinese manufacturers of ostomy bags serve the global market, including regions such as Europe, North America, South America, the Middle East, Southeast Asia, and Africa.
Can I Become an Exclusive Distributor of a Chinese Colostomy Bag Manufacturer?
Some Chinese manufacturers support regional agency and exclusive distributorship arrangements. Such partnerships typically require an evaluation based on market size, annual purchase volume, sales plans, and brand promotion capabilities, followed by the signing of a long-term cooperation agreement.
Do Chinese Colostomy Bag Manufacturers Provide After-Sales Support?
Manufacturers that engage in long-term partnerships typically provide distributors with product training, technical documentation, marketing imagery, sales support, and services for handling quality issues, thereby helping their partners enhance their competitiveness in local markets.
Do Chinese Colostomy Bag Manufacturers Provide Product Training for Distributors?
Professional manufacturers typically provide product information, usage training, technical documentation, and sales support to help distributors quickly understand product features and enhance their market promotion capabilities.
What Is the Lead Time for Bulk Colostomy Bag Orders?
Standard products typically have shorter lead times, whereas customized products require more time for packaging design, production, and quality inspection. Reliable manufacturers formulate production plans in advance based on order volumes to ensure a stable supply.
Conclusion: How to Choose the Best Colostomy Bag Manufacturer in China
When selecting a Chinese manufacturer of colostomy bags, the key lies in comprehensively evaluating qualifications, production capacity, and customization services. The first step is to ensure the manufacturer holds all necessary compliance credentials, such as medical device manufacturing licenses and product registration certificates; this is a non-negotiable baseline. Next, assess their ability to provide mature OEM/ODM services.
Choosing Zodelo as your partner guarantees complete peace of mind and strong market competitiveness. Zodelo holds authoritative international certifications—including ISO 13485, CE, and FDA—ensuring every product meets rigorous medical safety standards, while also demonstrating exceptional capabilities in OEM/ODM services.
At Zodelo, every stage of the process—from material selection to R&D—is driven by a single conviction: to minimize user inconvenience and enhance comfort. Zodelo stands by your side, dedicated to providing the most comfortable, safe, and reliable ostomy care products.
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