Blood Glucose Meter
by Beijing Yicheng Bioelectronics Technology Co., Ltd. 2 variants
Ref 113010012、113020009、113030013、113040013、113050009、113070017Model Model 5D-1、 Model 5D-2、Model 5D-3、Model 5D-6、 Model 5D-7、 Model 5D-8B
Withdrawn
CE IVDD, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06914329008668 06914329008668 | Date28 Dec 2025 | StatusWithdrawn |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Withdrawn
Specification
- Device Name
- Blood Glucose Meter
- Model / Reference
- Model 5D-1、 Model 5D-2、Model 5D-3、Model 5D-6、 Model 5D-7、 Model 5D-8B, 113010012、113020009、113030013、113040013、113050009、113070017
- Primary DI / UDI-DI
- 06914329008668
- Basic UDI-DI
- B-06914329008668
- EMDN Code
- W0201060102 Blood glucose meters
- Device Class
- Class IVD devices for self-testing
Manufacturer details
- EUDAMED SRN
- CN-MF-000033130
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Companion Diagnostics: No