Sairex Ky
FI-MF-000016116 · Finland · Kuopio
Sairex Ky is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|
Most frequent device types declared: 4207 / 4212 / 4215, 4160 / 4162 / 4175 / 4180, 3187a / 3188a / 3189a / 3190a, 4265 / 4267 / 4229 / 4235, 4110 / 4120 / 4115 / 4128 / 4126 / 4127.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | Finland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.