Koite Health Oy
FI-MF-000006901 · Finland · Espoo
Koite Health Oy is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: 01, 11, 03, 13, 10000mAh, 21, 60.
Among these devices, 7 are declared active.
Devices declared under this manufacturer
- Lumoral
- Lumoral Clinic
- Lumoral Junior
- Lumoral Treatment
- Lumoral protective plastic cover
- Lumorinse
Catalogue references include 01, 01, 03, 02-001, 03, 03, 13, 21.
European nomenclature codes declared: Z12040202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| 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 | 11 |
|---|---|
| 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. Koite Health Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI25/00000056 | issued | 2028-10-06 |