Precordior Oy
FI-MF-000014540 · Finland · Turku
Precordior Oy is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class IIa | 1 |
Among these devices, 5 are declared active, 5 with a measuring function.
Devices declared under this manufacturer
- CardioSignal
- CardioSignal Inside
Catalogue references include Android v. 1.0, Android v. 3.1, CardioSignal, iOS v. 1.0, iOS v. 3.1.
European nomenclature codes declared: Z12050892.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 4 |
|---|---|
| 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. Precordior Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1202-877-25 | supplemented | 2030-05-26 |