Pedihealth Oy
FI-MF-000000503 · Finland · Oulu
Pedihealth Oy is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: Tamla Boot Splint, Tamla Knee Splint, Tamla Wrist Splint.
Among these devices, 1 are declared with a measuring function.
Devices declared under this manufacturer
- Coxa-lasta L
- Coxa-lasta M
- Coxa-lasta S
- Coxa-lasta XL
- Coxa-lasta XXL
- Coxa-lasta XXS
- Tamla-rannelasta L
- Tamla-rannelasta M
- Tamla-rannelasta S
- Tamla-saapaslasta L
- Tamla-saapaslasta S
- Tamla-takalasta L
Showing 12 of 17 declared devices.
Catalogue references include 1563782, 1563808, 1563824, 1563832, 1563840, 1563857.
European nomenclature codes declared: M03050299, Y061215, V0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| 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 | 17 |
|---|---|
| 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. Pedihealth Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI25/00000046 | issued | 2030-07-29 |