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Glucofix Tech Gk
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 52076 FR/IT, 52077 FR-basic, 52078 NL, 56815 UK, 57170 FR-basic-E, 57168 FR, 57169 FR-E
Identity
- Trade Name
- GLUCOFIX TECH GK EUDAMED
- Device Name
- GLUCOFIX TECH GK Set EUDAMED
- Model / Reference
- 52076 FR/IT, 52077 FR-basic, 52078 NL, 56815 UK, 57170 FR-basic-E, 57168 FR, 57169 FR-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8012992BGMSMgluketUV2EP EUDAMED
- Basic UDI-DI
- B-8012992BGMSMgluketUV2EP EUDAMED
- EMDN Code
- W0101060101,W010106010801,W0101060110,W020106019099 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 Gk 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-8012992BGMSMgluketUV2EP | 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 5db36a45-9c11-40b0-9107-b6e802da4826-1 61 fields · synced Jun 19, 2026
- EUDAMED 5db36a45-9c11-40b0-9107-b6e802da4826-2 61 fields · synced Jun 19, 2026