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Silicone Foam Dressing
EUDAMEDClass IIb (EU MDR)
Ref GEN-14766Model Silicone Foam Dressing With Border (Type I)
Identity
- Device Name
- Silicone Foam Dressing EUDAMED
- Model / Reference
- Silicone Foam Dressing With Border (Type I) EUDAMEDGEN-14766 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327028019 EUDAMED
- Basic UDI-DI
- 694232708961GJ EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Silicone Foam Dressing by Winner Medical Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694232708961GJ | Class IIb | 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 (1)
- EUDAMED 8f1f5828-ecd2-427f-b9e4-2b42c750b3f2 61 fields · synced May 23, 2026