SEJOY Blood Glucose Monitoring System
by Sejoy Biomedical Co., Ltd. 7 variants
Ref BG-201
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06939663915571 06939663915571 | Date29 Sep 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Blood Glucose Monitoring System
- Model / Reference
- BG-201
- Primary DI / UDI-DI
- 06939663915571
- Basic UDI-DI
- B-06939663915571
- EMDN Code
- W0201060102 Blood glucose meters
- Device Class
- Class IVD Annex II List B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000008447
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Sejoy Biomedical Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Companion Diagnostics: No