Identity
- Trade Name
- Vlies-Einwegkittel EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- FN-IG0101 EUDAMED761050 EUDAMED761040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973911693804 EUDAMED06973911692388 EUDAMED
- Basic UDI-DI
- 697391169IG0101DE EUDAMED
- Unit of Use DI
- 06973911693798 EUDAMED06973911693521 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Vlies-Einwegkittel by Finess Healthcare Group Co., Ltd — Class I — 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 | 697391169IG0101DE | Class I | Active |
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Manufacturer
- Manufacturer
- Finess Healthcare Group Co., Ltd
- EUDAMED SRN
- CN-MF-000004124
- Authorised Representative
- Zoustech S.L. ES-AR-000002008
Sources (2)
- EUDAMED f8e59fb3-4776-4a64-9166-8a47c9bcc36b 61 fields · synced Oct 6, 2026
- EUDAMED eaf89638-69a9-406d-9069-ad8534db163c 61 fields · synced May 17, 2026