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FORA 6 Total Cholesterol Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACS055
Identity
- Trade Name
- FORA 6 Total Cholesterol Test Strip EUDAMED
- Device Name
- Total Cholesterol Test Strip EUDAMED
- Model / Reference
- ACS055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640143657902 EUDAMED07640143650088 EUDAMED07640143658664 EUDAMED
- Basic UDI-DI
- B-07640143657902 EUDAMEDB-07640143650088 EUDAMEDB-07640143658664 EUDAMED
- EMDN Code
- W0101060102 CHOLESTEROL TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMEDItaly 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 Total Cholesterol Test Strip 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-07640143657902 | 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 (3)
- EUDAMED 35153586-b11b-4902-ae8e-d0bb5d44bd98 61 fields · synced Jul 12, 2026
- EUDAMED 281d3ffe-5ccf-4a25-b7ed-4ee15d820334 61 fields · synced May 17, 2026
- EUDAMED ddbf4279-1280-4b7e-8471-4615fc2c1dc3 61 fields · synced May 17, 2026