Linksun Blood Glucose Test Strips
Ref G-425S-1Model G-427BS,G-425-2S
Active
CE IVDR
Valid until
16 Apr 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6939184600001AC | Date4 Jun 2025 | StatusActive |
Certificates
- V74 051313 0032 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 17 Apr 2025
- Expires
- 16 Apr 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Blood Glucose Test Strip
- Model / Reference
- G-427BS, G-425-2S, G-425S-1
- Primary DI / UDI-DI
- 06939184603049, 06939184603032
- Basic UDI-DI
- 6939184600001AC
- Direct Marketing DI
- 0693918460304906939184603032
- EMDN Code
- W0101060101 Glucose test strips
- Device Class
- Class C
- EU market of registration
- MaltaIreland
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
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No