Sleep Apnoea Therapy Devices
by Micomme Medical Technology Development Co., Ltd. 47 variants
Ref 0102004112Model C1, C2, C3, C5, B1, B5, S1, T1, T2, T3, T5, P1
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 | Number69593527RUYISERIESKP 06959352704330 | Date11 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- Withdrawn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
- C1, C2, C3, C5, B1, B5, S1, T1, T2, T3, T5, P1, 0102004112
- Primary DI / UDI-DI
- 06959352704330
- Basic UDI-DI
- 69593527RUYISERIESKP
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class IIa
- EU market of registration
- Italy
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.
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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