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Isolation gown
EUDAMEDClass I (EU MDR)
Ref BLOU000003Model FN-IG0101Ref HANDYB01W
Identity
- Trade Name
- Isolation gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- FN-IG0101 EUDAMEDBLOU000003 EUDAMEDHANDYB01W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973911697116 EUDAMED06973911697161 EUDAMED
- Basic UDI-DI
- 697391169IG0101DE EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) 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
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
Isolation 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 | 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 91ae41cf-9aba-4c99-8e3d-1f7ae3b36060 61 fields · synced Oct 6, 2026
- EUDAMED c73fecd9-f6f3-484d-abed-c9edccd2c6ad 61 fields · synced May 18, 2026