Identity
- Device Name
- Zinc Oxide Adhesive Plaster EUDAMED
- Model / Reference
- TZO002 EUDAMEDTZO001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327094021 EUDAMED16942327094038 EUDAMED
- Basic UDI-DI
- B-16942327094021 EUDAMEDB-16942327094038 EUDAMED
- EMDN Code
- M03030199 ELASTIC FIXING BANDAGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Zinc Oxide Adhesive Plaster by Winner Medical Co., Ltd. — Class I — 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-16942327094021 | Class I | 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 1a3a4a40-770d-47b9-bfbb-bdbcc02a2b4c 61 fields · synced Jul 9, 2026
- EUDAMED 12bf4d40-5a10-4355-a84f-57884991cb1a 61 fields · synced May 18, 2026