NIKE SRL
IT-MF-000030998 · Italy · orbetello
NIKE SRL is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 27 |
|---|
Most frequent device types declared: Dental Devices.
Devices declared under this manufacturer
- NIKE
- SPECCHIETTI
Showing 12 of 27 declared devices.
Catalogue references include Z-3400, Z-3401, Z-3402, Z-3403SD, Z-3404, Z-3404SD.
European nomenclature codes declared: L160201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 27 |
| 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 | 27 |
|---|---|
| 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. NIKE SRL was not found in either the U.S. or the Canadian register.