Occlutech GmbH
DE-MF-000005104 · Germany · Jena
Occlutech GmbH is registered in the European database on medical devices as a manufacturer, with 65 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 65 |
|---|
Among these devices, 65 are declared sterile, 50 implantable.
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 | Occlutech GmbH (DE) · FDA 3014616394 |
| Devices in EUDAMED | 65 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
51030-61-D0-00 | issued | 2031-05-06 |
51030-61-C0 | issued | 2028-06-28 |
51030-61-B0 | issued | 2028-06-28 |
51030-61-A0 | issued | 2027-09-01 |
51030-60-00-01 | supplemented | 2026-10-19 |