Identity
- Trade Name
- Impervious Cover Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- FN-IG0102 EUDAMED760520-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973911694979 EUDAMED06973911690261 EUDAMED
- Basic UDI-DI
- 697391169IG0102DG EUDAMED
- Unit of Use DI
- 06973911694962 EUDAMED06973911693514 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
Impervious Cover Gown 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 | 697391169IG0102DG | 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 d8963ea8-769d-47d2-8ef0-5f2ab4b0c3df 61 fields · synced Oct 6, 2026
- EUDAMED ce85f76a-cd36-4f71-b7ef-311f2c15de8d 61 fields · synced May 18, 2026