Identity
- Trade Name
- FORA 6 Connect EUDAMEDFORA 6 Connect Multi-Functional Monitoring System EUDAMED
- Device Name
- Blood Glucose Monitoring System EUDAMEDMulti-Functional Monitoring System EUDAMED
- Model / Reference
- GD82 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640402711284 EUDAMED07640402711840 EUDAMED07640402711345 EUDAMED07640402712250 EUDAMED07640143655199 EUDAMED
- Basic UDI-DI
- B-07640402711284 EUDAMEDB-07640402711840 EUDAMEDB-07640402711345 EUDAMEDB-07640402712250 EUDAMEDB-07640143655199 EUDAMED
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
FORA 6 Connect by ForaCare Suisse AG — Class IVD Annex II List B — 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-07640402711284 | Class IVD Annex II List B | 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 (5)
- EUDAMED bca9d358-c7d1-4b20-8a2a-e04188276b1a 61 fields · synced Jul 26, 2026
- EUDAMED 9c623f25-ef3b-46ea-8556-0fcd85251b2e 61 fields · synced May 16, 2026
- EUDAMED 65de0815-eeeb-4e9b-8f5e-759420ca5431 61 fields · synced May 16, 2026
- EUDAMED 05fe6e18-25db-454f-a8f5-6e7436510b61 61 fields · synced May 17, 2026
- EUDAMED 0821dab5-1159-404e-8ea6-6a5a25859f56 61 fields · synced May 19, 2026