Frescon Oy
FI-MF-000017377 · Finland · LEMPÄÄLÄ
Frescon Oy is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 15 |
|---|
Most frequent device types declared: #1002/ 75ml; #1003/ 150ml; #1004/ 500ml; #1009/ 50ml; #1010/ 7ml; #10, 170B, Cold Spray.
Among these devices, 1 are declared active.
Devices declared under this manufacturer
- Boreas Ice Gel 150 ml
- Boreas Ice Gel Roll-On 75 ml
- Boreas Pain Relief Cream
- Cool-X Cold Gel 50 ml
- Cool-X Cold Gel 500 ml
- Cool-X Cold Gel Roll-on 75 ml
- Cool-X Cold Spray
- Cool-X Cold-Hot Cream 100 ml
- Cool-X Hot-Cold Compress
- Cool-X Hot-Cold Compress Pearl
- Cool-X Kylmägeeli
- Cool-X Pain Relief Cream
Showing 12 of 15 declared devices.
Catalogue references include 1002B, 1003/151, 1003B, 1007, 1007B, 1012.
European nomenclature codes declared: M9001, V0999.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| 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 | 2 |
|---|---|
| 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. Frescon Oy was not found in either the U.S. or the Canadian register.