Blood Glucose Meter
by Bioland Technology Ltd. United States EUDAMED
Ref G-427BModel G-427B,G-425-2 EMDN W0201060102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6939184630001BD | Date4 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- V74 051313 0032 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 17 Apr 2025
- Expires
- 16 Apr 2030
Specification
- Model / Reference
- G-427B, G-425-2
- Primary DI / UDI-DI
- 06939184631516
- Basic UDI-DI
- 6939184630001BD
- Direct Marketing DI
- 06939184631516
- EMDN Code
- W0201060102 Blood glucose meters
- Device Class
- Class C
- Market of Registration
- Malta
Manufacturer details
- EUDAMED SRN
- CN-MF-000010625
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Bioland Technology Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 641ebb48-c606-4e68-b137-937eb54a35b0