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Data / Medical devices / United Kingdom / Motilent Ltd

Motilent Ltd: FDA-registered device maker in London England, United Kingdom, 1 510(k) clearance

Motilent Ltd is registered with the FDA (registration 3030179922) in London England, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3030179922
Address
Beyond, Aldgate Tower - Motilent Ltd. 2 Leman Street, London England, United Kingdom, E1 8FA
Owner or operator
Motilent LTD (10089117)
Roles
Complaint file establishment, Manufacturer
First device listed
November 7, 2023
Registered through
2026
Brand names listed
Entrolytics MD, GIQuant

Devices it lists

DeviceProduct codeClassRoleSource
System, Digital Image Communications, RadiologicalLMD1Complaint file establishment, Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishment, Manufactureraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 8, 2021K211356GIQuantLLZSubstantially EquivalentMotilent, Ltd.accessdata.fda.gov

Compare with other makers

Updated November 8, 2021. 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.