Distalmotion SA
CH-MF-000037226 · Switzerland · Epalinges
Distalmotion SA is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 5 |
|---|---|
| Class IIa | 7 |
Most frequent device types declared: Dexter L6.
Among these devices, 6 are declared sterile, 5 active.
Authorised representative in the Union: Distalmotion Deutschland GmbH.
Devices declared under this manufacturer
- Dexter
Catalogue references include 105, 140, 147, 339, 487, 512.
European nomenclature codes declared: K01020299, Z12020101, S010401, Z12029003, K01020203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DISTALMOTION SA (CH) · FDA 3033118964 |
| Devices in EUDAMED | 12 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 33.3 % |
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. Distalmotion SA is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HU24/00000124 | issued | 2029-10-15 |