AKTIVE SRL
IT-MF-000007813 · Italy · ROMA
AKTIVE SRL is registered in the European database on medical devices as a manufacturer, with 1 045 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 045 |
|---|
Most frequent device types declared: Laser Fiber Illuminated/Fibre Laser Illuminate, Vitrectomy Cutter/Vitrectomo , Retinal Chandelier/Candelieri , Phaco Needle/Punta Phaco, Knife/Bisturi .
Among these devices, 1 044 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AKTIVE SRL (IT) · FDA 3012481881 |
| Devices in EUDAMED | 1 045 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.22/5011.1 | reissued | 2027-12-13 |
EPT 0477.MDR.22/5010.1 | reissued | 2027-12-13 |