Project Engineering srl
IT-MF-000009571 · Italy · Impruneta
Project Engineering srl 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 | 6 |
|---|
Most frequent device types declared: Endless, On Demand, On Demand / Endless.
Among these devices, 6 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- MostCareUp
- Opthaem
Catalogue references include 08MC02 Rel: 02E, 08MC02 Rel:55E, 08MC0212E, 08MC0215E, 08OPT12E, 08OPT15E.
European nomenclature codes declared: Z1203020202.
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 Engineering srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 00154-A | issued | 2031-06-04 |