ASSKEA GmbH
DE-MF-000005146 · Germany · Gebesee
ASSKEA GmbH is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 66 |
|---|
Most frequent device types declared: Secretion Aspirators, Cuff Aspirators.
Among these devices, 27 are declared 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 | ASSKEA GMBH (DE) · FDA 3013857114 |
| Devices in EUDAMED | 66 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
111138U2 | issued | 2031-03-08 |