Project Blue Generation s.r.l.
IT-MF-000027914 · Italy · Bellaria - Igea Marina (RN)
Project Blue Generation s.r.l. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: 3M00, 7F00, BH900, EVO.1064, EVO.1064/E.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- EVOLASER 1064
- EVOLASER EASY 1064
- FIRING
- MAGNETOBOX
- MIXING2
- US13
Catalogue references include 3M00, 7F00, BH900, EVO.1064, EVO.1064/E, ILINE.US13.
European nomenclature codes declared: Z120615, Z120601,Z120610, Z120606, Z120610, Z12062899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. Project Blue Generation s.r.l. was not found in either the U.S. or the Canadian register.