Heated humidified high flow nasal cannula oxygen therapy device(HFNC)
by Micomme Medical Technology Development Co., Ltd. 4 variants
Ref /Model OH-60A, OH-70B, OH-70C
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69593527OHSERIESPT 06959352700592 | Date5 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- OH-60A, OH-70B, OH-70C, /
- Primary DI / UDI-DI
- 06959352700592
- Basic UDI-DI
- 69593527OHSERIESPT
- EMDN Code
- R060202 Oxygen administration humidification systems
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008694
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Micomme Medical Technology Development Co., Ltd.
See all devices from Micomme Medical Technology Development Co., Ltd. →
Properties
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