Identity
- Trade Name
- 4SURE Smart Duo EUDAMED
- Device Name
- Blood Glucose and 𝝱 Ketone Monitoring System EUDAMED
- Model / Reference
- GD87 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420040815542 EUDAMED
- Basic UDI-DI
- B-05420040815542 EUDAMED
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
Yes
EUDAMED
4SURE Smart Duo 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-05420040815542 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ForaCare Suisse AG
- EUDAMED SRN
- CH-MF-000019906
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 6f3e4463-6216-447c-8b1c-e1b2ff99c34d 61 fields · synced Aug 1, 2026