Heated humidified high flow nasal cannula oxygen therapy device(HFNC)
by Micomme Medical Technology Development Co., Ltd. China EUDAMED
Ref /Model OH-60A, OH-70B, OH-70C
EMDN R060202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69593527OHSERIESPT | Date5 Dec 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- OH-60A, OH-70B, OH-70C, /
- Primary DI / UDI-DI
- 06959352700578
- Basic UDI-DI
- 69593527OHSERIESPT
- EMDN Code
- R060202 Oxygen administration humidification systems
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008694
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 4899d101-e128-4e9b-8653-a7ed1c746af2