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 IIa | 3 |
| Class IIb | 4 |
Most frequent device types declared: CERACELL®, CERACELL® Ortho Mouldable Foam, CERASORB® Flexible Foam Strip, CERASORB® Mouldable Foam, IngeniOs® HA.
Among these devices, 61 are declared sterile, 65 implantable, 3 reusable, 1 active.
Devices declared under this manufacturer
- CERACELL®
- CERACELL® Ortho Mouldable Foam
- CERASORB® Bioactive
- CERASORB® Flexible Foam Strip
- CERASORB® Mouldable Foam
- IngeniOs® HA
- IngeniOs® β-TCP Bioactive
- OSBONE®
- STYPRO® Special
- STYPRO® Special XL
- STYPRO® Strip
- STYPRO® Tampon
Showing 12 of 70 declared devices.
Catalogue references include 0-602001, 0-901001, 9000050504, 9000810103, 9001 101 803, 9001102031.
European nomenclature codes declared: P900402, M040503, P900403, L99, L26.
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 |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CURASAN AG |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 4 |
| Class 4 devices | 1 |
| First licensed | 2010-10-29 |
Licence types: Device Family (5).
Licensed under: CERASORB ORTHO PURE-PHASE BETA-TRICALCIUM PHOS, CERASORB PURE-PHASE BETA-TRICALCIUM PHOSPHATE, INGENIOS BETA-TCP BIOACTIVE SYNTHETIC BONE PAR, HA SYNTHETIC BONE PARTICLES, CERASORB ORTHO FOAM.
North American profile: Both markets. curasan AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1010200127 | restricted | 2027-10-28 |
D1010200120 | cancelled | 2029-05-09 |