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FORA 6 ๐ฑ-Ketone Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACS053
Identity
- Trade Name
- FORA 6 ๐ฑ-Ketone Test Strip EUDAMED
- Device Name
- ๐ฑ-Ketone Test Strip EUDAMED
- Model / Reference
- ACS053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640143658008 EUDAMED
- Basic UDI-DI
- B-07640143658008 EUDAMED
- EMDN Code
- W0101060110 KETONE TEST STRIPS (ฮ-HYDROXYBUTYRATE TEST STRIPS) 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 ๐ฑ-Ketone Test Strip by ForaCare Suisse AG โ Class IVD devices for self-testing โ IVDD โ listed in EUDAMED โ regulatory data on deviCERTS
Authorization Coverage (European Union โ 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-07640143658008 | 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 f8acf970-6c8b-40d7-8636-a032ba03b68b 61 fields ยท synced Jun 18, 2026