Disior Oy
FI-MF-000002448 · Finland · HELSINKI
Disior Oy is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: Bonelogic 1.0, Bonelogic 2, Bonelogic 2.2, Bonelogic CMF Orbital, Bonelogic Neuro.
Among these devices, 5 are declared active, 3 with a measuring function.
Devices declared under this manufacturer
- Bonelogic CMF Orbital
- Bonelogic Neuro
- Disior Bonelogic 1.0
- Disior Bonelogic 2
- Disior Bonelogic 2.2
Catalogue references include Bonelogic 2, Bonelogic 2.2, Bonelogic CMF Orbital, Bonelogic Neuro, Bonelogic Ortho Foot and Ankle.
European nomenclature codes declared: Z110603.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DISIOR OY (FI) · FDA 3018064242 |
| Devices in EUDAMED | 5 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 3 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 66.7 % |
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: United States only. Disior Oy is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI20/00000020 | issued | 2026-05-30 |