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4SURE Level 1 KETONE CONTROL SOLUTION
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACS027
Identity
- Trade Name
- 4SURE Level 1 KETONE CONTROL SOLUTION EUDAMED
- Device Name
- 𝝱 Ketone Control Solution EUDAMED
- Model / Reference
- ACS027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420040815634 EUDAMED
- Basic UDI-DI
- B-05420040815634 EUDAMED
- EMDN Code
- W0101050299 SPECIFIC CONTROLS (CC) - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
4SURE Level 1 KETONE CONTROL SOLUTION by ForaCare Suisse AG — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05420040815634 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- ForaCare Suisse AG
- EUDAMED SRN
- CH-MF-000019906
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 7002d942-2bf5-4b3c-8e22-5ded95c00fe3 61 fields · synced Jul 14, 2026