Identity
- Trade Name
- Hydrocoll Classic EUDAMEDHydrocoll Classic (DE), 10x10 cm, P10 EUDAMED
- Device Name
- Hydrocolloid Dressing EUDAMED
- Model / Reference
- 5361140 EUDAMED536114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327041308 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 a4b15d0b-1275-46f4-acd4-925f0267a0de 61 fields · synced Jul 9, 2026
- EUDAMED a7bb1d3d-1bfa-46e2-9579-e3e473bdb9fe 61 fields · synced Jul 9, 2026