Blood Glucose Meter
by Cofoe Medical Technology Co., Ltd. 10 variants
Ref KFA101Model KF-A02-C
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-06950715500477 06950715500477 | Date17 Jul 2023 | 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- Withdrawn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
- Model / Reference
- KF-A02-C, KFA101
- Primary DI / UDI-DI
- 06950715500477
- Basic UDI-DI
- B-06950715500477
- EMDN Code
- W0201060102 Blood glucose meters
- Device Class
- Class IVD Annex II List B
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000001077
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Cofoe Medical Technology 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