Data / Medical devices / Germany / Tni Medical AG

Tni Medical AG: FDA-registered device maker in Wurzburg Bavaria, Germany, 1 510(k) clearance

Tni Medical AG is registered with the FDA (registration 3010063021) in Wurzburg Bavaria, 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 3, 2026.

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FDA registration number

3010063021

Address

Nurnberger Str. 74a, Wurzburg Bavaria, Germany, 97076

Owner or operator

TNI medical AG (10051448)

Roles

Complaint file establishment, Manufacturer

First device listed

January 27, 2021

Registered through

2026

Brand names listed

TNI softFlow 50 Hospital System 10-50L

Devices it lists

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.

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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.