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Non-woven Wound Dressing
EUDAMEDClass I (EU MDR)
Ref GEN-15810Ref NWD1130ERef NWD003Ref NWD001Ref GEN-15610
Identity
- Device Name
- Non-woven Wound Dressing EUDAMED
- Model / Reference
- GEN-15810 EUDAMEDNWD1130E EUDAMEDNWD003 EUDAMEDNWD001 EUDAMEDGEN-15610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327076133 EUDAMED16942327036878 EUDAMED16942327094014 EUDAMED16942327093994 EUDAMED16942327000374 EUDAMED
- Basic UDI-DI
- 694109409841GE EUDAMEDB-16942327094014 EUDAMEDB-16942327093994 EUDAMED
- EMDN Code
- M040199 PREPARED DRESSINGS - OTHER EUDAMEDM04010201 NON-WOVEN FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Non-woven Wound Dressing by Winner Medical Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 694109409841GE | Class I | Active |
| EUDAMED | European Union | CE/MDR | 694109409841GE | Class I | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000005692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 5296e3c3-c72c-4fd1-ac4b-a194c102942f 61 fields · synced Sep 17, 2026
- EUDAMED 29c95d87-9b9a-46a7-bf68-a3d808bde1c2 61 fields · synced May 16, 2026
- EUDAMED f364a6aa-52f8-40e8-bf6f-045883d0d25b 61 fields · synced May 17, 2026
- EUDAMED 3b7522cc-60a8-4508-99e5-cc9ad72ce5c5 61 fields · synced May 18, 2026
- EUDAMED e34fe0aa-0c3b-4742-abca-c25c4bc452cd 61 fields · synced May 18, 2026