Identity
- Trade Name
- Hydrocoll Classic (Concave) EUDAMEDHydrocoll Classic (Concave), 8x12 cm, P10 EUDAMED
- Device Name
- Hydrocolloid Dressing EUDAMED
- Model / Reference
- 5361250 EUDAMED536125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327001562 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 (Concave) 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 77a46157-d185-4810-a33a-752206fe46cb 61 fields · synced Jul 24, 2026
- EUDAMED 04435bfd-4ece-4a7d-82d5-49d83b0c18d5 61 fields · synced Jul 24, 2026