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Non-Surgical Gowns
EUDAMEDClass I (EU MDR)
Ref ZLCOV005Model S,M,L,XL,XXLRef ZLCOV001Ref ZLCOV003
Identity
- Trade Name
- NON-SURGICAL GOWNS EUDAMED
- Device Name
- NON-SURGICAL GOWNS EUDAMED
- Model / Reference
- S,M,L,XL,XXL EUDAMEDZLCOV005 EUDAMEDZLCOV001 EUDAMEDZLCOV003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974742160821 EUDAMED16974742160784 EUDAMED16974742160807 EUDAMED
- Basic UDI-DI
- 697474216MPCUD 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
Non-Surgical Gowns by Farstar Medical Hubei 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 | 697474216MPCUD | Class I | Active |
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Manufacturer
- Manufacturer
- Farstar Medical Hubei Ltd.
- EUDAMED SRN
- CN-MF-000017294
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 0b421d85-a7b1-4c73-b66e-2d4b85a61cdd 61 fields · synced Sep 17, 2026
- EUDAMED 226516a0-caa8-47bb-9c04-b30808190ec3 61 fields · synced May 17, 2026
- EUDAMED 0f67f61e-5ceb-44ca-ac78-fe00a82882de 61 fields · synced May 19, 2026