Lincotek Bologna S.r.l
IT-MF-000033944 · Italy · Cadriano di Granarolo Emilia (BO)
Lincotek Bologna S.r.l is registered in the European database on medical devices as a manufacturer, with 516 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 417 |
|---|---|
| Class IIb | 66 |
| Class IIa | 33 |
Most frequent device types declared: Trinity™ PLUS Evo Screw, Trinity™ PLUS Evo Cup Size 62 Taper Size 5 Ti6Al4V (Astm F2924), Trinity™ PLUS Evo Cup Size 70 Taper Size 5 Ti6Al4V (Astm F2924) Cap, Trinity™ PLUS Evo Cup Size 70 Taper Size 5 Ti6Al4V (Astm F2924), Trinity™ PLUS Evo Cup Size 54 Taper Size 4 Ti6Al4V (Astm F2924).
Among these devices, 483 are declared sterile, 483 implantable, 33 reusable.
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 | LINCOTEK BOLOGNA S.R.L. (IT) · FDA 3016778562 |
| Devices in EUDAMED | 516 |
| Country of registration | Italy |