Asensus Surgical Italia S.r.l.
IT-MF-000007964 · Italy · Milano
Asensus Surgical Italia S.r.l. is registered in the European database on medical devices as a manufacturer, with 141 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 132 |
|---|---|
| Class IIb | 9 |
Most frequent device types declared: Senhance Adapters, Senhance Connect, Senhance Motorized Adapters, Senhance Surgical Instruments, Senhance Surgical System.
Among these devices, 1 are declared sterile, 50 reusable, 10 active.
Devices declared under this manufacturer
- Adapter, Passive Babcock Forceps, Ø 5 mm x 310 mm
- Adapter, Passive Mixter Dissector Ø 5 mm x 240 mm
- Adapter, Passive Needle Holder Right Ø 5 mm x 240 mm
- Adapter, Passive Right Angle Dissector, Ø 10 mm x 310 mm
- Babcock Forceps Ø 5 mm x 310 mm
- DeBakey Grasper Ø 3 mm x 280 mm
- Fundus Grasper Ø 5 mm x 240 mm
- Intelligent Surgical Unit
- Johan Grasper 15 mm Tip Ø 5 mm x 240 mm
- Monopolar Maryland Dissector Ø 3 mm x 280 mm
- Needle Holder Left Ø 5 mm x 310 mm
- Needle Holder Right Ø 5 mm x 310 mm
Showing 12 of 141 declared devices.
Catalogue references include X0007004, X0007017, X0007023, X0007218, X9007013, X9007019.
European nomenclature codes declared: Z1202018099, L1399, L1303, Z12020101, L1304, L1306.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Asensus Surgical Italia, S.r.l. (IT) · FDA 3012880598 |
| Devices in EUDAMED | 141 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 141 |
|---|---|
| Found in the U.S. device database | 127 |
| Share | 90.1 % |
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. Asensus Surgical Italia S.r.l. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1024597 1 | amended | 2027-06-30 |