GimaCare β-Ketone Test Strip
by TaiDoc Technology Corporation
Ref TD-4633
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-08023279241334 08023279241334 | Date13 Aug 2026 | 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- Withdrawn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
- β-Ketone Test Strip
- Model / Reference
- TD-4633
- Primary DI / UDI-DI
- 08023279241334
- Basic UDI-DI
- B-08023279241334
- EMDN Code
- W0101060110 Ketone test strips (β-hydroxybutyrate test strips)
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- TW-MF-000017956
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Taidoc Technology Corporation
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Companion Diagnostics: No
- Surgical Instrument: No