Medical Face Mask
by Xiantao Chenguang Protection Commodity Co., Ltd. China EUDAMED
Ref 16217Model FM001
EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697478283FM001LD | Date5 Jun 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Face Mask
- Model / Reference
- FM001, 16217
- Primary DI / UDI-DI
- 06974782830145
- Basic UDI-DI
- 697478283FM001LD
- Direct Marketing DI
- 06974782830145
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000025794
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 8e0acc6e-d7e1-4050-8ef8-b2db6c268cec