Olympus Winter & Ibe GmbH
DE-MF-000006729 · Germany · Hamburg
Olympus Winter & Ibe GmbH is registered in the European database on medical devices as a manufacturer, with 238 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 123 |
|---|---|
| Class IIb | 115 |
Among these devices, 4 are declared reusable, 119 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 | OLYMPUS WINTER & IBE GMBH (DE) · FDA 9610773 |
| Devices in EUDAMED | 238 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1845129-1 | supplemented | 2025-04-20 |
HZ 1845129-1 | supplemented | 2030-04-20 |