Dr. Max ThermoMax Digital Baby
by Famidoc Technology Co., Ltd.
Ref FDTH-V0-3
Active
CE MDR
Valid until
10 Jul 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN23/00003635 | Date30 Sep 2024 | StatusActive |
Certificates
- CN23/00003635 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 30 Sep 2024
- Expires
- 10 Jul 2028
- Reason
- Mnf ar change
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Digital Clinical Thermometer
- Model / Reference
- FDTH-V0-3
- Primary DI / UDI-DI
- 06970389631475
- Basic UDI-DI
- 697038963FDTHV0RA
- EMDN Code
- V0301010201 Contact digital thermometers (including probes)
- Device Class
- Class IIa
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000016603
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Famidoc Technology Company Limited
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