Airex AG
CH-MF-000014202 · Switzerland · Sins
Airex AG is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 75 |
|---|
Most frequent device types declared: Balance-Trainer, Gymnastic mat.
Authorised representative in the Union: 3A Composites GmbH.
Devices declared under this manufacturer
- Atlas Water blue
- Balance-pad Elite Blue
- Balance-pad Mini Lava
- Balance-pad XLarge Blue
- Balance-pad XLarge Lava
- Corona 185 Slate
- Coronella 185 Blue
- Coronella 185 Blue Eyelets
- Fitline 140 Pink
- Fitline 140 Water blue Eyelets
- Fitline 180 Kiwi
- Hercules Water blue
Showing 12 of 75 declared devices.
Catalogue references include BALANCEPADELIMILA, BALANCEPADELITE, BALANCEPADXL, CORONASIEP, CORONELLABLEP, FITLINE140PIEP.
European nomenclature codes declared: Z120603.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 75 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 75 |
|---|---|
| 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. Airex AG was not found in either the U.S. or the Canadian register.