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Data / Medical devices / United Kingdom / Phagenesis Limited

Phagenesis Limited: FDA-registered device maker in Manchester Lancashire, United Kingdom, 1 510(k) clearance

Phagenesis Limited is registered with the FDA (registration 3014265054) in Manchester Lancashire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 16, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3014265054
Address
Unit 18 Enterprise House Manchester Science Park, Manchester Lancashire, United Kingdom, M156SE
Owner or operator
Phagenesis Limited (10086158)
Roles
Complaint file establishment, Specification developer
First device listed
December 15, 2022
Registered through
2026
Brand names listed
The Phagenyx System

Devices it lists

DeviceProduct codeClassRoleSource
Oropharyngeal Electrical StimulatorQQG2Complaint file establishment, Specification developeraccessdata.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
September 16, 2022DEN220025Phagenyx SystemQQGUnknownPhagenesis Limitedaccessdata.fda.gov

Updated September 16, 2022. 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.