OSYPKA GmbH
DE-MF-000005610 · Germany · Rheinfelden
OSYPKA GmbH is registered in the European database on medical devices as a manufacturer, with 126 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 95 |
|---|---|
| Class IIa | 30 |
| Class IIb | 1 |
Most frequent device types declared: CX Cable, Pacing Cables, TX Cable, iCONNECT System Cable, PK Cable.
Among these devices, 113 are declared sterile, 1 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OSYPKA GmbH (DE) · FDA 3003923762 |
| Devices in EUDAMED | 126 |
| Country of registration | Germany |