United Kingdom MHRA device registration 149025

Coagulation factor IX IVD, kit, chromogenic

United Kingdom·In Vitro Diagnostic Device·Precision BioLogic Inc.·Registered Nov 26, 2024

Registration details

Device ID: 149025
MHRA Reference Number: 149025
Date Registered: Nov 26, 2024
Last Updated: Apr 17, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Coagulation factor IX IVD, kit, chromogenic
Type: IVD General

Manufacturer

Name: Precision BioLogic Inc.
Address: 140 Eileen Stubbs Avenue
Dartmouth, Nova Scotia, Canada
Created Date: Nov 24, 2021

Authorized Representative

Name: Emergo Consulting (UK) Limited
Relationship Type: UK Responsible Person
Address: Compass House, Vision Park Histon c/o Cr360 – UL International
Cambridge, England, United Kingdom
Postcode: CB24 9BZ

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About this record

Coagulation factor IX IVD, kit, chromogenic is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 149025. The device is manufactured by Precision BioLogic Inc. from Canada, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) Limited .

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