Intersurgical SpA
IT-MF-000010729 · Italy · Mirandola - MO
Intersurgical SpA is registered in the European database on medical devices as a manufacturer, with 826 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 821 |
|---|---|
| Class IIb | 5 |
Most frequent device types declared: Interflow Voxy, STARBALL, Starvent 2, TWINFUSER.
Among these devices, 5 are declared active.
Devices declared under this manufacturer
- STARMED
Showing 12 of 826 declared devices.
Catalogue references include CP1050L/2, CP1052, CP1132XXL/2R, CP1161L/2R, CP1358XL/2, CP1476XL/2RZ.
European nomenclature codes declared: R9099, R0301010401, R0301010402, R0301010202, R03010180, R03010202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INTERSURGICAL LTD. (GB) · FDA 3002807267 |
| Devices in EUDAMED | 826 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 826 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 0.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | INTERSURGICAL LTD. |
What it holds in Canada
| Licences on record | 62 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 62 |
| First licensed | 1999-06-10 |
Licence types: Device Family (38), Single Device (11), Device Group Family (10), System (2).
Licensed under: NEOPRENE RESERVOIR BAGS - LATEX FREE, LATEX FREE SILICONE ANAESTHETIC FACE MASKS, BREATHING SYSTEM (VENTILATOR) TUBING - SILICON, NEOPRENE ANATOMICAL FACE MASKS - LATEX FREE, HUMIDIFIER ELECTRICAL ADAPTOR LEADS, LARYNGOSCOPE BLADES.
North American profile: Both markets. Intersurgical SpA is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1344699 1 | supplemented | 2028-01-24 |