A. MENARINI Diagnostics S.r.l.
IT-MF-000023427 · Italy · Firenze
A. MENARINI Diagnostics S.r.l. is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Cleaning solution, Reagent.
Devices declared under this manufacturer
- Aution wash solution
- GLUCOFIX TECH B-Ketone Control
- GLUCOFIX TECH B-Ketone Sensor
- GLUCOFIX TECH Control
- GLUCOFIX TECH GK
- GLUCOFIX TECH Sensor
- GlucoMen areo
- GlucoMen areo B-Ketone Sensor
- GlucoMen areo Control
- GlucoMen areo GK
- GlucoMen areo Sensor
- PRIME MDx DNA/RNA Extraction kit 2 x48 rxn
Showing 12 of 17 declared devices.
Catalogue references include 31111, 46203, 46211,46210, 46213, 49261, 48742, 46214, 46215, 46212, 46627 NL, 46626, 46623 FR, 46622 FR10,47688 FR 50, 48587 IT, 48586 IT1, 48106,48105,49245,48103,48688,48101,47953,47951,47952,48703,48820,4882, 48591 (IT/FR/NL), 48592 (IT/FR/NL), 61555 (UK), 61556 (UK), 52076 FR/IT, 52077 FR-basic, 52078 NL, 56815 UK, 57170 FR-basic-E, 571.
European nomenclature codes declared: W010106010801, W0101060101,W010106010801,W0101060110,W020106019099, W0101060110, W0101060101,W010106010801,W0201060102, W0101060101, W0105900101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 4 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. A. MENARINI Diagnostics S.r.l. was not found in either the U.S. or the Canadian register.