Fetal Monitors
by Shenzhen Unicare Electronic Co., Ltd.
Ref RD-R-QP008-002/A/0Model MCF-21K
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 | Number69512176FMMCF21KW4 | Date27 Mar 2023 | 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- Withdrawn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
- MCF-21K, RD-R-QP008-002/A/0
- Primary DI / UDI-DI
- 06951217621042, 06951217621103
- Basic UDI-DI
- 69512176FMMCF21KW4
- Direct Marketing DI
- 0695121762104206951217621103
- EMDN Code
- Z12080101 Foetal monitors
- Device Class
- Class IIa
- EU market of registration
- SpainItaly
Manufacturer details
- EUDAMED SRN
- CN-MF-000032694
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Unicare Electronic 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