Data / Medical devices / Germany / Mechatronic GmbH
Mechatronic GmbH: FDA-registered device maker in Hoehn Rhineland-Palatinate, Germany, 1 510(k) clearance
Mechatronic GmbH is registered with the FDA (registration 3018900343) in Hoehn Rhineland-Palatinate, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018900343
- Address
- Am Gewerbepark 2, Hoehn Rhineland-Palatinate, Germany, 56462
- Owner or operator
- TNI medical AG (10051448)
- Roles
- Remanufacturer, Repackager or relabeler
- First device listed
- January 27, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Remanufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 18, 2018 | K180474 | TNI softFlow 50 | BTT | Substantially Equivalent | Tni Medical AG | accessdata.fda.gov |
Compare with other makers
Updated October 18, 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.