Respiratory High-flow Therapy Device
by Shenzhen SunnyGrand Healthcare Technology Co., Ltd. EUDAMED
Active
Ref NatrFlow 50HModel NatrFlow
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- Withdrawn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
- Respiratory High-flow Therapy Device
- Model / Reference
- NatrFlow, NatrFlow 50H
- Primary DI / UDI-DI
- 06974340680212
- Basic UDI-DI
- 697434068A121D8
- Direct Marketing DI
- 06974340680212
- EMDN Code
- R060201 Active ventilation humidification systems,
- Device Class
- Class IIa
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000017209
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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Properties
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