Identity
- Trade Name
- NON-SURGICAL GOWNS EUDAMED
- Device Name
- NON-SURGICAL GOWNS EUDAMED
- Model / Reference
- S,M,L,XL,XXL EUDAMEDZLCOV002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974742160791 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 (1)
- EUDAMED 154cbf11-8bf5-4b60-a03b-0d15157672a4 61 fields · synced Jun 19, 2026