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: IN000196, IN000279, INO FLOW SENSOR NEXT/ADVANCED, Mobile Cart, NO Gas Hose.
Among these devices, 61 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- Additional patient tube 15 mm, 1pcs/pkg
- INO MONITORING 15MM
- INO MONITORING LUER ELBOW PACK
- Low flow sensor
- MONNAL INO ADVANCED
- MONNAL iNO
- Mobile Cart
- SOKINOX
- SOKINOX NEXT
- SoKINOX
- SoKINOX NEXT
- TUBE BUNNELL
Showing 12 of 85 declared devices.
Catalogue references include IN000132, IN000150, IN000267, IN000302, IN000308, IN000333.
European nomenclature codes declared: Z1203019002, Z1203019080, Z1203019099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INOSYSTEMS (FR) · FDA 3019771924 |
| Devices in EUDAMED | 85 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 83 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | INOSYSTEMS SA |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2015-03-02 |
Licence types: System (1).
Licensed under: SOKINOX NO DELIVERY AND MONITORING SYSTEM.
North American profile: Both markets. INOSYSTEMS is registered in both the United States and Canada.