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 IIb | 66 |
|---|---|
| Class I | 417 |
| Class IIa | 33 |
Most frequent device types declared: Acetabular Cup-R D.46 D Trabecular CaP, Augment D.54 +18 mm Trabecular CaP, Femoral Head Ceramic Biolox®Delta D.40 S, Trinity™ PLUS Evo Augment Size 62-64 Thickness +18 Cap, Trinity™ PLUS Evo Cup Size 62 Taper Size 5 Ti6Al4V (Astm F2924).
Among these devices, 483 are declared sterile, 483 implantable, 33 reusable.
Devices declared under this manufacturer
- Bipolar - Box
- Double Mobility Press
- Generic Box/Tray (1 Level Box- Empty)
- Generic Box/Tray (2 Level Box - Empty)
- Generic Box/Tray (Box Costrained Liner)
- Generic Box/Tray (Box Cup All Instruments - No Preparation)
- Generic Box/Tray (Box Cup All Instruments)
- Generic Box/Tray (Stemmed Cup - Box)
- MIS Levers - Box
- MIS Stem P - Box
- Stem Osteotome - Box
- Stem P - Box
Showing 12 of 516 declared devices.
Catalogue references include BO76.2908.000.00, BO76.2983.000.00, BO76.3113.000.00, BO76.3178.000.00, BO76.3223.000.00, BO76.3302.000.00.
European nomenclature codes declared: P090803040101, P090803010201, P09088099, P090804050201, V0402, P0908030302.
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 |
Device-level evidence
| Devices with a numeric GTIN | 516 |
|---|---|
| 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: United States only. Lincotek Bologna S.r.l is registered in the United States but was not found in the Canadian register.