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Fora 6
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACS055Ref S057321Model ACS057
Identity
- Trade Name
- FORA 6 EUDAMED
- Device Name
- Total Cholesterol Test Strip EUDAMEDUric Acid Test Strip EUDAMED
- Model / Reference
- ACS055 EUDAMEDACS057 EUDAMEDS057321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640402710133 EUDAMED07640402710119 EUDAMED
- Basic UDI-DI
- B-07640402710133 EUDAMEDB-07640402710119 EUDAMED
- EMDN Code
- W0101060102 CHOLESTEROL TEST STRIPS EUDAMEDW0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany 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
Fora 6 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-07640402710133 | 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 (2)
- EUDAMED a2ceeed4-9128-419a-8358-48b57c30201d 61 fields · synced Jul 31, 2026
- EUDAMED 96afa50a-5720-40e5-b815-e72dccd96841 61 fields · synced May 18, 2026