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Transparent Wound Dressing
EUDAMEDClass I (EU MDR)
Ref DRF002Ref TFD2150ERef DRF003
Identity
- Device Name
- Transparent Wound Dressing EUDAMED
- Model / Reference
- DRF002 EUDAMEDTFD2150E EUDAMEDDRF003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327094052 EUDAMED16942327042411 EUDAMED16942327094069 EUDAMED
- Basic UDI-DI
- B-16942327094052 EUDAMED694109409847GS EUDAMEDB-16942327094069 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMEDM04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Transparent Wound Dressing by Winner Medical Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-16942327094052 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-16942327094052 | 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 (3)
- EUDAMED e274a2ba-a78f-4c45-a6a1-7cc58ec314da 61 fields · synced Jul 27, 2026
- EUDAMED 7aaadeff-0e6c-4460-a8b0-70163f490e33 61 fields · synced May 18, 2026
- EUDAMED 8e5453f9-a578-4a11-bd49-06a21a5f55f8 61 fields · synced May 18, 2026