Heart2Save Oy
FI-MF-000004794 · Finland · Kuopio
Heart2Save 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 IIa | 5 |
|---|
Most frequent device types declared: Awario Care White.
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- Awario Analysis Service
- Awario Application
- Awario Care
- Awario Care 2
- Awario Gem
Catalogue references include 1010, 2010, 3010, 3012, 4010.
European nomenclature codes declared: C020501, Z12050392.
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 | 5 |
|---|---|
| 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. Heart2Save Oy was not found in either the U.S. or the Canadian register.