FORA Control Solution Normal
Ref ACS015
Withdrawn
CE IVDD, withdrawn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Withdrawn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-07640402710126 07640402710126 | Date22 Jun 2026 | 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- Withdrawn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European Union — CE/IVDD Withdrawn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 Control Solution
- Model / Reference
- ACS015
- Primary DI / UDI-DI
- 07640402710126
- Basic UDI-DI
- B-07640402710126
- EMDN Code
- W0101050205 Diabetes controls
- Device Class
- Class IVD Annex II List B
Manufacturer details
- EUDAMED SRN
- CH-MF-000019906
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from ForaCare Suisse AG
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Companion Diagnostics: No
- Surgical Instrument: No