Data / Medical devices / Germany / Medentis Medical GMBH
Medentis Medical GMBH: FDA-registered device maker in Bad Neuenahr-Ahrweiler Rhineland-Palatinate, Germany, 1 510(k) clearance
Medentis Medical GMBH is registered with the FDA (registration 3015961056) in Bad Neuenahr-Ahrweiler Rhineland-Palatinate, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015961056
- Address
- Walporzheimer Strasse 48-52, Bad Neuenahr-Ahrweiler Rhineland-Palatinate, Germany, 53474
- Owner or operator
- Medentis Medical GmbH (10061248)
- Roles
- Exporter to the US
- First device listed
- October 3, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2018 | K173041 | 3DIEMME RealGUIDE | LLZ | Substantially Equivalent | 3Diemme , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 20, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.