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Export
EU MDR Certified Wound Care Dressing Exporter from India
Trusted Manufacturer & Global Export Partner for Hospitals, Distributors, and OEM Buyers — Serving 25+ Countries with ISO 13485 Certified Products
- EU MDR Certified
- ISO 13485 Certified
- CE Marked Product
- 25+ Export Countries
Worldwide Exporter of Surgical Dressing and Medical Disposable Products from India
Medicare Hygiene Ltd. is a leading manufacturer and global exporter of high-quality wound care and surgical dressing products, backed by over 30 years of manufacturing excellence. With a strong presence in more than 25 countries — including key European markets such as Italy, Poland, and the United Kingdom — we supply hospitals, distributors, and healthcare institutions with ISO 13485 certified and EU MDR compliant medical products. Our extensive product portfolio includes Gauze Compress, Lap Sponges, Paraffin Gauze Dressings, Chlorhexidine Gauze Dressings, Elastic Adhesive Bandages, Zinc Oxide Adhesive Plaster, Non-Woven Adhesive Tapes, Ortho Roll Cast Padding, and a comprehensive range of medical PVC disposables — all manufactured at our state-of-the-art facility in Ahmedabad, India.
For European distributors and procurement teams, Medicare Hygiene offers a complete export partnership — from CE marked product supply and full EU MDR documentation to OEM manufacturing and private label packaging. Whether you are sourcing gauze compress for surgical use, IV infusion sets for hospital supply, or seeking an Indian manufacturing partner for custom branded wound care products, we are equipped to support your procurement requirements with consistency, compliance, and competitive pricing. We currently serve healthcare distributors and institutional buyers across Europe, the Middle East, Africa, Asia-Pacific, and other international markets.
Wound Care and Surgical Dressing Product Range
Medicare Hygiene Ltd. manufactures a comprehensive range of CE certified wound care and surgical dressing products, designed for hospitals, surgical centers, and healthcare institutions worldwide. Our wound care range is compliant with EU MDR 2017/745, ISO 13485, and is available with full export documentation for European buyers. Product range include:
- Gauze Range
- Wound Care Dressing
- Ortho Range
- Medical Tapes
- Infection Prevention
Medical Disposable Product Range for Export
Our medical PVC disposable products are manufactured under strict EO sterilization conditions with full batch traceability and quality documentation. Ideal for hospital bulk procurement and distributor supply, our disposable range includes:
- Transfusione
- Respiratory
- Urology
- Gastroenterology
- Surgery
Why Choose Medicare Hygiene Ltd. as Your Export Partner
Key Technical Product Specifications
- 100% absorbent cotton & medical-grade raw materials
- Multiple ply options, thread count & GSM configurations
- Sterile (EO) & non-sterile variants available
- High absorbency, lint-free performance
- Long shelf life with validated packaging
- Flexible packaging: bulk / retail / hospital / OEM
Export Certifications & Compliance
- ISO 13485:2016 Certified (Quality Management System)
- CE Marked Products — EU MDR 2017/745 Compliant
- CE Certificate: MD Class IIa & IIb (EU Notified Body)
- WHO-GMP Compliance (applicable product categories)
- Country-specific regulatory approvals available
- Full export documentation: CE cert, DoC, CoA, MSDS
Export Capability & Logistics
- Exporting to 25+ countries across Europe, Middle East, Africa, Asia-Pacific
- MOQ flexible — as per buyer requirement and product type
- Lead time: 3–5 weeks from order confirmation
- Shipping via Air & Sea freight, CIF / FOB / EXW terms
- Flexible port of dispatch from Nhava Sheva / Mundra
- OEM & private labelling support for all product lines
Quality Assurance Process
- Strict in-house quality inspections at every production stage
- EO sterilization validation as per ISO 11135
- Full batch traceability and documentation
- Bioburden estimation and sterility testing
- Packaging integrity testing
- Class 10,000 & 100,000 cleanroom manufacturing
Customization & Private Labellings
- Custom product sizes & technical specifications
- Brand packaging design & custom labelling
- Multilingual packaging (English, French, German, Arabic, etc.)
- OEM manufacturing for European distributors
Our Commitment to Europe Export Compliance
Medicare Hygiene Ltd. holds CE certification for wound care and surgical dressing products classified under Medical Device Class IIa and IIb, issued by a recognized EU Notified Body in compliance with EU MDR Regulation 2017/745. This makes our products among the few Indian-manufactured wound care products that are fully authorized for import and distribution within European Union member states.
Our export documentation for European buyers includes:
- CE Certificate of Conformity — covering applicable product categories
- Declaration of Conformity (DoC) — EU MDR 2017/745 compliant
- ISO 13485:2016 Certificate — Quality Management System
- Certificate of Analysis (CoA) per batch
- Material Safety Data Sheet (MSDS) where applicable
- Sterilization validation records (EO sterilization as per ISO 11135)
- Shelf life and stability data
- Country-of-origin documentation (India)
Our product range includes sterile gauze compress, paraffin gauze dressings, non-woven adhesive dressings, IV securement dressings, orthopaedic casting materials, and a wide range of medical PVC disposables — all backed by traceable batch documentation and quality assurance systems that meet European import requirements.
Distributor Partnership Program — Europe & Global
We actively partners with medical distributors, importers, and healthcare supply companies across Europe, the Middle East, Africa, and Asia-Pacific. We offer a structured distributor support model designed to make procurement, logistics, and compliance as straightforward as possible for our partners.
| What We Offer — Logistics & Compliance | What We Offer — OEM & Partnership |
|---|---|
| Flexible MOQ based on product type | OEM and private label manufacturing |
| Lead time: 3–5 weeks from order | Custom product specifications on request |
| Air freight & sea freight options | Multilingual packaging (EN, FR, DE, AR...) |
| FOB / CIF / EXW terms available | Territory exclusivity arrangements |
| Dedicated export documentation support | Dedicated account management |
| CE & ISO certificates provided per shipment | Sample shipments for product evaluation |
Whether you are an established European medical distributor seeking a reliable Indian manufacturing partner, or an institutional buyer looking to source CE certified wound care products directly, we welcome the opportunity to discuss your requirements.
Frequently Asked Questions (FAQs)
1. Are Medicare Hygiene products EU MDR certified?
A: Yes. Medicare Hygiene Ltd. holds CE certification for wound care and surgical dressing products classified as Medical Device Class IIa and IIb under EU MDR Regulation 2017/745, issued by a recognized EU Notified Body. Full compliance documentation including the Declaration of Conformity is available upon request.
2. Do you support OEM manufacturing and private labelling?
A: Yes. We provide complete OEM manufacturing and private label services, including custom product specifications, brand packaging design, multilingual labelling (English, French, German, Arabic, and more), and custom lot sizes. Our OEM programme is designed for European distributors and global healthcare brands.
3. What export documentation do you provide?
A: We provide a full set of export documents including CE Certificate, Declaration of Conformity (DoC), ISO 13485 Certificate, Certificate of Analysis (CoA), MSDS, sterilization validation records, packing list, and country-of-origin certificate. Additional country-specific documentation can be arranged on request.
4. What are your typical export lead times?
A: Standard lead times are 3 to 5 weeks from order confirmation, depending on product type, quantity, and packaging requirements. For repeat orders with established distributors, lead times may be shorter. OEM and custom orders may require additional time.
5. Which countries does Medicare Hygiene export to?
A: We currently export to 25+ countries including Italy, Poland, United Kingdom, Kuwait, Oman, Qatar, Australia, New Zealand, Nepal, Sri Lanka, Bangladesh, Fiji, Papua New Guinea, Mauritius, Kenya, Tanzania, Zambia, Ghana, Malawi, Togo, Sudan, Malaysia, Trinidad and Tobago, Republic of Congo, Liberia, and Panama. We are actively expanding our European and Middle East distribution networks.
6. What sterilization methods are used for your products?
A: Our sterile product lines are processed using Ethylene Oxide (EO) sterilization, validated in compliance with ISO 11135. Sterilization is performed at our facility in Ahmedabad, India, and all sterile products carry full batch traceability and sterilization validation records.
7. Can you supply products with custom packaging for our brand?
A: Yes. We offer complete private label and OEM packaging solutions including branded pouches, carton boxes, multilingual labels, and hospital-specific pack sizes. All custom packaging is produced in compliance with EU MDR labelling requirements.
8. What is the minimum order quantity (MOQ) for exports?
A: MOQ varies by product category and packaging type. We accommodate flexible order quantities for initial trials and sample evaluations, with standard commercial MOQs applied for repeat orders. Please contact our export team with your specific requirements for a tailored quotation.
