Cpap and Niv Masks
by Shenzhen SunnyGrand Healthcare Technology Co., Ltd. China EUDAMED
Ref AF01Model AF EMDN R0301010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697434068AFZ7 | Date26 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cpap and Niv Masks
- Model / Reference
- AF, AF01
- Primary DI / UDI-DI
- 06974340681578
- Basic UDI-DI
- 697434068AFZ7
- EMDN Code
- R0301010201 Cpap masks
- Device Class
- Class IIa
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000017209
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Shenzhen SunnyGrand Healthcare Technology Co., Ltd.
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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 06974340681578|697434068AFZ7