Neonavia AB
SE-MF-000045971 · Sweden · Vallentuna
Neonavia AB is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Among these devices, 3 are declared sterile, 2 active.
Devices declared under this manufacturer
- NeoNavia CorePulse probe
- NeoNavia FlexiPulse probe
- NeoNavia VacuPulse probe
- NeoNavia base unit
- NeoNavia driver
Catalogue references include REF# 1102, REF# 1103, REF# 2102, REF# 2103, REF# 2104.
European nomenclature codes declared: A01020199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NEONAVIA AB (SE) · FDA 3042940295 |
| Devices in EUDAMED | 5 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 40.0 % |
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: United States only. Neonavia AB is registered in the United States but was not found in the Canadian register.