Blood Glucose Meter
by Contec Medical Systems Co., Ltd. 21 variants
Ref BGM10A-BVModel BGM10A，BGM10A-BV，BGM10A-L，BGM10B，BGM10B-BV，BGM10B-L，BGM10C，BGM10C-BV，BGM10C-L，BGM10D，BGM10D-BV，BGM10D-L，BGM10E，BGM10E-BV，BGM10E-L，BGM10F，BGM10F-BV，BGM10F-L，BGM10G，BGM10G-BV，BGM10G-L
Active
CE IVDR
Valid until
26 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 050972 0062 | Date27 Aug 2026 | StatusActive |
Certificates
- V76 050972 0062 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 27 Aug 2026
- Expires
- 26 Aug 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- BGM10A，BGM10A-BV，BGM10A-L，BGM10B，BGM10B-BV，BGM10B-L，BGM10C，BGM10C-BV，BGM10C-L，BGM10D，BGM10D-BV，BGM10D-L，BGM10E，BGM10E-BV，BGM10E-L，BGM10F，BGM10F-BV，BGM10F-L，BGM10G，BGM10G-BV，BGM10G-L, BGM10A-BV
- Primary DI / UDI-DI
- 06945040113492
- Basic UDI-DI
- 69450401BGM10FH
- Direct Marketing DI
- 06945040113492
- EMDN Code
- W0201060102 Blood glucose meters
- Device Class
- Class C
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000007715
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Contec Medical Systems Co., Ltd.
Properties
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