Identity
- Trade Name
- Hydrocoll Classic EUDAMEDHydrocoll Classic, 10x10 cm, P3 EUDAMED
- Device Name
- Hydrocolloid Dressing EUDAMED
- Model / Reference
- 5361120 EUDAMED536112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327072197 EUDAMED
- Basic UDI-DI
- 694109403536EU EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Hydrocoll Classic 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 | 694109403536EU | 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 (2)
- EUDAMED e31c080d-92f4-4495-80e3-c0792a07de7b 61 fields · synced Jul 11, 2026
- EUDAMED f072df40-8352-4997-b782-a1505301b452 61 fields · synced Jul 11, 2026