EUROSETS S.R.L.
IT-MF-000023171 · Italy · Medolla
EUROSETS S.R.L. is registered in the European database on medical devices as a manufacturer, with 215 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 213 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: EUDSS.
Among these devices, 172 are declared sterile, 2 reusable, 2 active.
Devices declared under this manufacturer
- ADULT ECMO SET 14 DAYS CH
- ADULT SET 14D BRAUNSCHWEIG D
- COLIBRÌ TABLET HOLDER
- CUVETTE 1/4 LAND.COATED STER.
- ECMO PEDIATRIC 1/4x3/32 MALAGA
- FILLING SET W/BAG ROTENBURG D
- HOLDER FOR AMG PMP OXY MODULE
- HOLDER PRIMING BAG2000ml RIGHT
- HOSE EXTENSION 3 m
- Holder for ALONE ECMO
- KOMPASS A.L.ONE
- LINEA ASPIRAZIONE ANTICOAG. I
Showing 12 of 215 declared devices.
Catalogue references include 14AG0131, 14AG0133, 14AG0321, AG5087, EU2257, EU5100.
European nomenclature codes declared: C03010301, V80, C030180, C03010102, B0401, Z12050280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Eurosets s.r.l. (IT) · FDA 3003752502 |
| Devices in EUDAMED | 215 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 215 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | EUROSETS SRL |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 6 |
| First licensed | 2021-09-24 |
Licence types: Single Device (3), System (2), Device Group (1).
Licensed under: A.M.G. MODULE PMP NO T.P. CA, AMG PMP ADULT SET CA, A.M.G.PMP PEDIATRIC STE CA, REMOWELL 2 AF PLUS, A.M.G.PMP NEW BORN STE CA, TRILLY PED.AF FULL COATED STE.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 024169 0060 | supplemented | 2027-09-29 |