Eisenbacher Dentalwaren ED GmbH
DE-MF-000008322 · Germany · Wörth am Main
Eisenbacher Dentalwaren ED GmbH is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Devices declared under this manufacturer
- Kera N
- Kera NH
- Kera-Disc
- Robur 400
Showing 12 of 14 declared devices.
Catalogue references include 1004003, 10041208, D10041108, D10041210, D10041212, D10041216.
European nomenclature codes declared: Q010601.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EISENBACHER DENTALWAREN ED GMBH (DE) · FDA 3004971271 |
| Devices in EUDAMED | 14 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EISENBACHER DENTALWAREN ED GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2025-06-26 |
Licence types: Device Family (1).
Licensed under: KERA S-POWDER.
North American profile: Both markets. Eisenbacher Dentalwaren ED GmbH is registered in both the United States and Canada.