Data / Medical devices / Germany / AKTORmed GmbH
AKTORmed GmbH: FDA-registered device maker in Neutraubling Bavaria, Germany, 6 510(k) clearances
AKTORmed GmbH is registered with the FDA (registration 3011390076) in Neutraubling Bavaria, Germany. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011390076
- Address
- Neugablonzer Strasse 13, Neutraubling Bavaria, Germany, 93073
- Owner or operator
- AKTORmed GmbH (10059606)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- February 4, 2019
- Registered through
- 2027
- Brand names listed
- AKTORmed Probe Cover 30cm x 178cm, ARTip solo, Dexter Endoscope Arm, ENDOSCOPE HOLDER, Endofix EXO, Robofix, SOLOASSIST II, SOLOASSIST IID and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | 2 | Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US | accessdata.fda.gov |
| Endoscope Holder | OCV | 2 | Manufacturer | accessdata.fda.gov |
| Software Controlled Endoscope And Instrument Holder | QZB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 20, 2026 | K261573 | ENDOSCOPE HOLDER (182214) | QZB | Substantially Equivalent | Aktormed GmbH | accessdata.fda.gov |
| August 8, 2024 | K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | QZB | Substantially Equivalent | Aktormed GmbH | accessdata.fda.gov |
| April 25, 2024 | K232405 | ENDOFIX EXO | OCV | Substantially Equivalent | Aktormed GmbH | accessdata.fda.gov |
| December 22, 2020 | K200473 | SoloAsisst II, Voice Control | NAY | Substantially Equivalent | Aktormed GmbH | accessdata.fda.gov |
| September 21, 2018 | K171947 | SOLOASSIST II | NAY | Substantially Equivalent | Aktormed GmbH | accessdata.fda.gov |
| September 20, 2010 | K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscope Holder
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Drape, Surgical, Antimicrobial
- All makers of Software Controlled Endoscope And Instrument Holder
- All makers of Drape, Surgical, Exempt
Updated July 20, 2026. 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.