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 IIa | 30 |
|---|---|
| Class I | 95 |
| Class IIb | 1 |
Most frequent device types declared: CX Cable, VACS II 12.0 x 20, VACS II 12.0 x 40, VACS II 12.0 x 60, VACS II 18.0 x 40.
Among these devices, 113 are declared sterile, 1 active.
Devices declared under this manufacturer
- CELSIUS - iCONNECT
- CX-BSW-Abbott
- Cable D2P-SP |white|L=2500|
- VACS II 12.0 x 20
- VACS II 12.0 x 40
- VACS II 12.0 x 60
- VACS II 18.0 x 40
- VACS II 18.0 x 60
- VACS II 22.0 x 50
- VACS II 26.0 x 30
- VACS II 6.0 x 20
- VACS III 18.0 x 30
Showing 12 of 126 declared devices.
Catalogue references include 82017, YA0025, YA0044, YA0046, YA0058, YA31830.
European nomenclature codes declared: C019014, C020399, C020299, C020299,C020499.
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 |
Device-level evidence
| Devices with a numeric GTIN | 126 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 1.6 % |
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. OSYPKA GmbH is registered in the United States but was not found in the Canadian register.