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Glucofix Tech
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 46639 , 46634, 46635, 46636, 46637, 49573, 51344
Identity
- Trade Name
- GLUCOFIX TECH EUDAMED
- Device Name
- GLUCOFIX TECH EUDAMED
- Model / Reference
- 46639 , 46634, 46635, 46636, 46637, 49573, 51344 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8012992BGMSMgluD82G6 EUDAMED
- Basic UDI-DI
- B-8012992BGMSMgluD82G6 EUDAMED
- EMDN Code
- W0101060101,W010106010801,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Netherlands 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 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-8012992BGMSMgluD82G6 | 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 bdc5107d-db59-40e7-a409-d1af1012bbd4-1 61 fields · synced Jul 29, 2026
- EUDAMED bdc5107d-db59-40e7-a409-d1af1012bbd4-2 61 fields · synced Jul 29, 2026