Monivent AB
SE-MF-000019004 · Sweden · Göteborg
Monivent AB is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 2 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- Monivent Neo100 Mask Adapter
- Monivent Neo100 System
Catalogue references include 100-SM, Monivent Neo100 Sensor Mask 66, N100-AD, N100-MA40, N100-MA52, N100-SY.
European nomenclature codes declared: R03010199, Z1203019003, Z1203019080.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Monivent AB was not found in either the U.S. or the Canadian register.