Punto Azzurro srl
IT-MF-000056386 · Italy · Rovetta
Punto Azzurro srl is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: TA0010 0000 MED, TA0011 0000 MED, TA0020 0000 MED.
Devices declared under this manufacturer
- TA-SK ARM COMPRESSION SLEEVE
- TA-SK LOWER LEG COMPRESSION SLEEVE
- TA-SK UPPER LEG COMPRESSION SLEEVE
Showing 12 of 14 declared devices.
Catalogue references include TA0010 0000 MED, TA0011 0000 MED, TA0020 0000 MED.
European nomenclature codes declared: M030405.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| 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 | 14 |
|---|---|
| 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. Punto Azzurro srl was not found in either the U.S. or the Canadian register.