Sorin Group Italia S.r.L.
IT-MF-000027510 · Italy · Milan
Sorin Group Italia S.r.L. is registered in the European database on medical devices as a manufacturer, with 354 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 316 |
|---|---|
| Class IIb | 38 |
Most frequent device types declared: AB2492, AB5023, AB5036, AB5044, C24551ND.
Among these devices, 326 are declared sterile, 28 reusable.
Devices declared under this manufacturer
- B-Capta
- BMR1900
- BRACKETS
- CONNECTOR
- GOCCIA
- INSPIRE
- KIDS
- LILLIPUT
- MIDICARD
- PTS
- SNAPPER PLATE
- SUCTION TIP
Showing 12 of 354 declared devices.
Catalogue references include 050584J, 050598, 050705J, 05214, 05217, 05234.
European nomenclature codes declared: C03010199, C03010101, C03010102, B0401, C030180, B0480.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SORIN GROUP ITALIA S.R.L (IT) · FDA 9680841 |
| Devices in EUDAMED | 354 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 354 |
|---|---|
| Found in the U.S. device database | 108 |
| Share | 30.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SORIN GROUP ITALIA S.R.L. |
What it holds in Canada
| Licences on record | 22 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 17 |
| Class 3 devices | 5 |
| First licensed | 1999-06-29 |
Licence types: Device Family (10), Device Group Family (9), System (3).
Licensed under: DIDECO CARDIOPLEGIA, STOCKERT CANNULA - ARTERIAL / VENOUS, PEDIATRIC HOLLOW FIBER OXYGENATORS, HEMOCONCENTRATORS, CARDIOPULMONARY BYPASS CIRCUIT BUBBLE TRAPS, PERFUSION TUBING SYSTEMS.
North American profile: Both markets. Sorin Group Italia S.r.L. is registered in both the United States and Canada.