LINKVERSE S.R.L.
IT-MF-000029440 · Italy · Rome
LINKVERSE S.R.L. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 3 |
Most frequent device types declared: GGM100, GGM300.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- ColonPRO™ EU
- GI Genius™ Module 100
- GI Genius™ Module 200
- GI Genius™ Module 300
- GI Genius™ software
Catalogue references include CB1708-SW3, CPRO41-EU, CPRO41S-EU, GGM100, GGM200, GGM300-EU.
European nomenclature codes declared: Z12029080, Z12020692.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LINKVERSE S.R.L. (IT) · FDA 3018901422 |
| Devices in EUDAMED | 6 |
| Country of registration | Italy |
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 | Licensed in Canada |
|---|---|
| Matched entry | LINKVERSE S.R.L. |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 1 |
| First licensed | 2021-11-16 |
Licence types: Single Device (2).
Licensed under: GI GENIUS INTELLIGENT ENDOSCOPY MODULE, GI GENIUS SOFTWARE.
North American profile: Both markets. LINKVERSE S.R.L. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.23/5274.1 | reissued | 2028-10-30 |