Data / Medical devices / Germany / Airamed GMBH
Airamed GMBH: FDA-registered device maker in Tuebingen Baden-Wurttemberg, Germany, 1 510(k) clearance
Airamed GMBH is registered with the FDA (registration 3035707772) in Tuebingen Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035707772
- Address
- Konrad-Adenauer-Str. 13, Tuebingen Baden-Wurttemberg, Germany, 72072
- Owner or operator
- AIRAmed GmbH (10094569)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 8, 2025
- Registered through
- 2026
- Brand names listed
- AIRAscore
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 25, 2023 | K223180 | AIRAscore | LLZ | Substantially Equivalent | Airamed GmbH | accessdata.fda.gov |
Compare with other makers
Updated August 25, 2023. 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.