INOSYSTEMS
FR-MF-000011282 · France · ANTONY
INOSYSTEMS is registered in the European database on medical devices as a manufacturer, with 85 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 63 |
|---|---|
| Class IIa | 22 |
Most frequent device types declared: NO Gas Hose, Sampling line, Mobile Cart, iNO Transport Enclosure, INO FLOW SENSOR NEXT/ADVANCED.
Among these devices, 61 are declared active, 2 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INOSYSTEMS (FR) · FDA 3019771924 |
| Devices in EUDAMED | 85 |
| Country of registration | France |