Data / Medical devices / United Kingdom / Calcivis Limited

Calcivis Limited: FDA-registered device maker in Edinburgh Scotland, United Kingdom, 1 PMA approval

Calcivis Limited is registered with the FDA (registration 3014024087) in Edinburgh Scotland, United Kingdom. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated March 7, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3014024087

Address

9 Edinburgh BioQuarter 9 Little France Road, Edinburgh Scotland, United Kingdom, EH164UX

Owner or operator

Calcivis Limited (10087618)

Roles

Specification developer

First device listed

March 20, 2023

Registered through

2026

Brand names listed

Calcivis Imaging System

Devices it lists

PMA approvals

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

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Updated March 3, 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.