Geuder AG
DE-MF-000008044 · Germany · Heidelberg
Geuder AG is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 4 |
Among these devices, 3 are declared sterile, 4 active.
Catalogue references include G-34500, G-90001, G-90002, G-90003, G-90010, G-90011.
European nomenclature codes declared: Z1212020702, A06030401, Q021101, Z1212020780.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GEUDER AG (DE) · FDA 9616245 |
| Devices in EUDAMED | 7 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GEUDER AG |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| First licensed | 2014-12-05 |
Licence types: Single Device (5), System (1), Device Group (1), Device Family (1).
Licensed under: SINGLE-USE DMEK CARTRIDGE, XENOTRON III, SZURMAN DMEK RAPID TRANSPORTATION AND INJECTIO, GEUDER SINGLE-USE GLASS CANNULA WITH PLUGS, SINGLE USE-TUBING WITH LUER CONNECTOR, SAAD UNFOLDING CANNULA.
North American profile: Both markets. Geuder AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 742901 | supplemented | 2028-07-18 |