Microlife Multiplex Multi-Monitoring System
by General Life Biotechnology Co., Ltd. EUDAMED
Active
Ref BX-M060
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-BX-M060Q8 | Date2 Feb 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Blood glucose, uric acid, and total cholesterol multi-monitoring system
- Model / Reference
- BX-M060
- Primary DI / UDI-DI
- D-BX-M060Q8
- Basic UDI-DI
- B-BX-M060Q8
- EMDN Code
- W0201069099 Various rapid test chemistry / immunochemistry instruments - other
- Device Class
- Class IVD Annex II List B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000027109
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from General Life Biotechnology Co., Ltd.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Companion Diagnostics: No