Data / Medical devices / Germany / Airnergy International GMBH
Airnergy International GMBH: FDA-registered device maker in Hennef/Sieg North Rhine-Westphalia, Germany, 1 510(k) clearance
Airnergy International GMBH is registered with the FDA (registration 3004139830) in Hennef/Sieg North Rhine-Westphalia, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 5, 2006. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004139830
- Address
- Wehrstrasse 24-26, Hennef/Sieg North Rhine-Westphalia, Germany, D-53773
- Owner or operator
- Airnergy International GmbH (10037391)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 11, 2011
- Registered through
- 2026
- Brand names listed
- Airnergy Medical Plus, Airnergy Stream Infrared Lamp
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Exporter to the US | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| September 5, 2006 | K052492 | AIRNERGY+STREAM | ILY | Substantially Equivalent | Natural Energy Solutions AG | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Lamp, Infrared, Therapeutic Heating
Updated September 5, 2006. 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.