medentis medical GmbH
DE-MF-000007754 · Germany · Bad Neuenahr-Ahrweiler
medentis medical GmbH is registered in the European database on medical devices as a manufacturer, with 177 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 177 |
|---|
Most frequent device types declared: Torque transmitting instrument.
Among these devices, 45 are declared sterile.
Devices declared under this manufacturer
- ICX AIO Wash Tray empty
- ICX impression cap blue, sterile
- ICX impression post closed
- ICX scan body, sterile MDK incl. Schraube/screw
- Maximus model analog
- OCC scan body
- Royal impression post closed incl. schmaler Kappe/slim cap
- da Vinci XC scan body, sterile D=3.3mm incl. Schraube/screw
- da Vinci XL model analogue NC
- da Vinci XL scan body, sterile RC incl. Schraube/screw
- da Vinci XS lab screw D=3.5/4.0mm, M1,6, hex=1.3
- da Vinci XT abutment holder D=3.4mm
Showing 12 of 177 declared devices.
Catalogue references include BLNC-006-010003, BLRC-030-000001S, C-005-020009, C-005-070006, C-030-000002, TW1000004-10.
European nomenclature codes declared: Q010207, Z12119099, P01020180, L159099, Z12110199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDENTIS MEDICAL GMBH (DE) · FDA 3015961056 |
| Devices in EUDAMED | 177 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 177 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. medentis medical GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1753171-1 | issued | 2028-08-30 |