Data / Medical devices / Sweden / Occlutech International AB

Occlutech International AB: FDA-registered device maker in Helsingborg Skane, Sweden, 1 PMA approval

Occlutech International AB is registered with the FDA (registration 3012613541) in Helsingborg Skane, Sweden. 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

3012613541

Address

Landskronavagen 2, Helsingborg Skane, Sweden, 25232

Owner or operator

Occlutech Holding AG (10084004)

Roles

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.