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GLUCOFIX TECH B-Ketone Sensor
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 48726 NL, 49911 FR, 50404 FR-E, 50415 FR, 48583 IT, 57171 UK-IT-FR
Identity
- Trade Name
- GLUCOFIX TECH B-Ketone Sensor EUDAMED
- Device Name
- GLUCOFIX TECH B-Ketone Sensor EUDAMED
- Model / Reference
- 48726 NL, 49911 FR, 50404 FR-E, 50415 FR, 48583 IT, 57171 UK-IT-FR EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8012992BGMSSketEF2KQ EUDAMED
- Basic UDI-DI
- B-8012992BGMSSketEF2KQ EUDAMED
- EMDN Code
- W0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
GLUCOFIX TECH B-Ketone Sensor by A. MENARINI Diagnostics S.r.l. — 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-8012992BGMSSketEF2KQ | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- A. MENARINI Diagnostics S.r.l.
- EUDAMED SRN
- IT-MF-000023427
Sources (2)
- EUDAMED 29b5b91a-3b5e-4bd3-9706-a0e8577b8c23-1 61 fields · synced Jul 14, 2026
- EUDAMED 29b5b91a-3b5e-4bd3-9706-a0e8577b8c23-2 61 fields · synced Jul 14, 2026