curasan AG
DE-MF-000008316 · Germany · Kleinostheim
curasan AG is registered in the European database on medical devices as a manufacturer, with 70 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 63 |
|---|---|
| Class IIb | 4 |
| Class IIa | 3 |
Most frequent device types declared: CERACELL®, OSBONE® , IngeniOs® β-TCP Bioactive, IngeniOs® HA , CERASORB® Mouldable Foam.
Among these devices, 61 are declared sterile, 65 implantable, 3 reusable, 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 | CURASAN AG (DE) · FDA 3003771570 |
| Devices in EUDAMED | 70 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1010200127 | restricted | 2027-10-28 |
D1010200120 | cancelled | 2029-05-09 |