Jpap
Ref 10055201001
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 | Number458029510110BN 04580295101119 | Date30 May 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- Withdrawn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
- Device Name
- Continuous Positive Airway Pressure Unit
- Model / Reference
- 10055201001
- Primary DI / UDI-DI
- 04580295101119
- Basic UDI-DI
- 458029510110BN
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- JP-MF-000038066
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Metran Co., Ltd.
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