United Kingdom MHRA device registration 111701

Pregabalin IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·ARK Diagnostics, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 111701
MHRA Reference Number: 111701
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Pregabalin IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: ARK Diagnostics, Inc.
Address: 48089 Fremont Blvd
Fremont, California, United States
Created Date: Nov 8, 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

Pregabalin IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 111701. The device is manufactured by ARK Diagnostics, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) Limited .

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