Identity
- Trade Name
- Hydrocoll Classic (Sacral) EUDAMEDHydrocoll Classic (Sacral), 12x18 cm, P3 EUDAMED
- Device Name
- Hydrocolloid Dressing EUDAMED
- Model / Reference
- 5361230 EUDAMED536123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327040523 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 (Sacral) 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 d46082f2-8876-400b-be79-aa173087d9a8 61 fields · synced Jun 18, 2026
- EUDAMED 610283d1-de8e-4f7b-bd7b-9982aacd7894 61 fields · synced Jun 18, 2026