Key4Product srl
IT-MF-000035891 · Italy · Bari
Key4Product srl is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 40 |
|---|
Devices declared under this manufacturer
- HOLOS IPER
- HOLOS IPO
- HOLOS NORMO
- HOLOS-CS
- HOLOS-CT
- HOLOS-R COMPLETE
- HOLOS-R MINIMAL
- HOLOS-V COMPLETE
- HOLOS-V MINIMAL
- HOLOS-Y COMPLETE
- HOLOS-Y MINIMAL
- HOLOS–CS
Showing 12 of 40 declared devices.
Catalogue references include MIO-1CS, MIO-2RC, MIO-2VC, MIO-3YM, MIO-4CS, MIO-4YC.
European nomenclature codes declared: Q010499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 40 |
| 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 | 40 |
|---|---|
| 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. Key4Product srl was not found in either the U.S. or the Canadian register.