Identity
- Device Name
- Alginate Dressing EUDAMED
- Model / Reference
- ALG001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327094083 EUDAMED
- Basic UDI-DI
- B-16942327094083 EUDAMED
- EMDN Code
- M04040201 ALGINATE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Alginate Dressing by Winner Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16942327094083 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
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 e16c91e9-1b52-4235-9d69-f9021d4edfcd 61 fields · synced May 23, 2026