Medentika GmbH
DE-MF-000009117 · Germany · Hügelsheim
Medentika GmbH is registered in the European database on medical devices as a manufacturer, with 1 025 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 025 |
|---|
Most frequent device types declared: Drill stop, Implant pick-up, MedentiGuide placement instrument, PROCONE surgical drill, Placement instrument.
Among these devices, 294 are declared reusable.
Devices declared under this manufacturer
- MEDENTiKA
Showing 12 of 1 025 declared devices.
Catalogue references include 4-14-72, 4-32-09, AT 40 RT, EV 63 SB, H 1410, H 40 RK.
European nomenclature codes declared: L159099, Q010599.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Medentika GmbH (DE) · FDA 3026444199 |
| Devices in EUDAMED | 1 025 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 1 025 |
|---|---|
| Found in the U.S. device database | 626 |
| Share | 61.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDENTIKA GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2026-05-22 |
Licence types: Device Family (1).
Licensed under: CUSTOM ABUTMENT AND CUSTOM ABUTMENT AS.
North American profile: Both markets. Medentika GmbH is registered in both the United States and Canada.