Sairex Oy
FI-MF-000039541 · Finland · Kuopio
Sairex Oy 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 |
|---|
Most frequent device types declared: 1565/1566/1566X, 3187a / 3188a / 3189a /3190a, 4110 / 4120 / 4115 / 4128 / 4126 / 4127, 4160 / 4162 / 4175 / 4180, 4201.
Devices declared under this manufacturer
- Sairex
Catalogue references include 1565/1566/1566X, 3187a / 3188a / 3189a /3190a, 4110 / 4120 / 4115 / 4128 / 4126 / 4127, 4160 / 4162 / 4175 / 4180, 4201, 4265 / 4267 / 4229 / 4235.
European nomenclature codes declared: V08068099, Y180980, V08068002, V0811, Y090699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Finland |
⚠️ 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. Sairex Oy was not found in either the U.S. or the Canadian register.