UFSK-International OSYS GmbH
DE-MF-000013511 · Germany · Regensburg
UFSK-International OSYS GmbH is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|
Most frequent device types declared: Assistant's Chair, Instrument Table, Surgeon's Chair, Transport- and relaxing chair, Treatment Chair.
Among these devices, 24 are declared active.
Devices declared under this manufacturer
- 500 ECO
- 500 XLE
- 500 XLS
- assistPro F
- assistPro H
- easyLine F
- easyPro R
- motionLine
- motionLine-E
- surgiForce with comfort seat
- surgiForce with formed seat
- surgiLine with comfort seat
Showing 12 of 24 declared devices.
Catalogue references include 15000005, 17000000, 17000001, 22000013, 24000005, 24000009.
European nomenclature codes declared: V08020199, V080202, V08020101, V080502, V0899.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | UFSK-INTERNATIONAL OSYS GMBH (DE) · FDA 3004438145 |
| Devices in EUDAMED | 24 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| Found in the U.S. device database | 22 |
| Share | 91.7 % |
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. UFSK-International OSYS GmbH is registered in the United States but was not found in the Canadian register.