Data / Medical devices / Germany / Occlutech GmbH

Occlutech GmbH: FDA-registered device maker in Jena Thuringia, Germany, 1 PMA approval

Occlutech GmbH is registered with the FDA (registration 3014616394) in Jena Thuringia, Germany. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated December 29, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3014616394

Address

Winzerlaer Strasse 2, Jena Thuringia, Germany, 07745

Owner or operator

Occlutech Holding AG (10084004)

Roles

Complaint file establishment, Manufacturer

First device listed

January 17, 2024

Registered through

2026

Brand names listed

Occlutech ASD Occluder and Occlutech Pistol Pusher

Devices it lists

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Compare with other makers

• All makers of Transcatheter Septal Occluder (Atrial)

Updated June 5, 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.