Sleep Apnoea Breathing Therapy Device
by Shenzhen SunnyGrand Healthcare Technology Co., Ltd. China EUDAMED
Ref NatrSleep 25S PlusModel NatrMeet, NatrSleep, NatrRes EMDN Q03010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI23/1008003 | Date27 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- FI23/1008003 Supplemented
Quality management system EU MDR
- Notified body
- SGS FIMKO OY 0598
- Issued
- 27 Sep 2025
- Expires
- 23 Oct 2028
- Reason
- Other
Specification
- Device Name
- Sleep Apnoea Breathing Therapy Device
- Model / Reference
- NatrMeet, NatrSleep, NatrRes, NatrSleep 25S Plus
- Primary DI / UDI-DI
- 06974340680786
- Basic UDI-DI
- 697434068A101&A111WW
- Direct Marketing DI
- 06974340680786
- EMDN Code
- Q03010201 Radiofrequency antisnoring and obstructive sleep apnoea devices
- Device Class
- Class IIa
- Market of Registration
- Iceland
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 ca64396c-ed9a-48d0-ad69-d2a5301af082