Data / Medical devices / Switzerland / Aktiia SA

Aktiia SA: FDA-registered device maker in Neuchatel, Switzerland, 1 510(k) clearance

Aktiia SA is registered with the FDA (registration 3019575688) in Neuchatel, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number

3019575688

Address

Rue du Bassin 8a, Neuchatel, Switzerland, 2000

Owner or operator

Aktiia SA (10092031)

Roles

Complaint file establishment, Manufacturer, Specification developer

First device listed

February 11, 2026

Registered through

2027

Brand names listed

Aktiia Init I1, G0 Blood Pressure Monitoring System, Hilo Cuff

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.

Compare with other makers

• All makers of System, Measurement, Blood-Pressure, Non-Invasive

Updated July 2, 2025. 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.