Identity
- Device Name
- 16g21”圆帽 EUDAMED
- Model / Reference
- 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974742169032 EUDAMED
- Basic UDI-DI
- 697474216PSM7OO7NKY EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
16g21”圆帽 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 | 697474216PSM7OO7NKY | 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 71e80642-a172-44cf-9b60-2899cf22cb37 61 fields · synced Jun 19, 2026