Data / Medical devices / Humidifier, Respiratory Gas, (Direct Patient Interface) / Germany
FDA-registered makers of Humidifier, Respiratory Gas, (Direct Patient Interface) in Germany: 5 establishments
5 establishments in Germany are registered with the FDA to make Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Product code
- BTT
- Country
- Germany
Makers of Humidifier, Respiratory Gas, (Direct Patient Interface) in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mechatronic GmbH | Hoehn Rhineland-Palatinate, Germany | Remanufacturer, Repackager or relabeler | 1 | October 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Tni Medical AG | Wurzburg Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | October 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Thora Tech GmbH | Giesen Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VBM Medizintechnik GMBH | SULZ AM NECKAR Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wilamed GMBH | Kammerstein Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.