United Kingdom MHRA device registration 162090

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Jiangsu KeyGEN BioTECH Co., Ltd.·Registered Dec 1, 2022

Registration details

Device ID: 162090
MHRA Reference Number: 162090
Date Registered: Dec 1, 2022
Last Updated: Dec 22, 2022

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Jiangsu KeyGEN BioTECH Co., Ltd.
Address: Building 6, No.18 Zhilan Road, Jiangning Science Park, Jiangning District
Nanjing City, Jiangsu Province, China
Created Date: Dec 1, 2022

Authorized Representative

Name: HUMISS COMPANY LIMITED
Relationship Type: UK Responsible Person
Address: Suite 145 82-84 Bell Yard
London, England, United Kingdom
Postcode: WC2A 2JR

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About this record

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 162090. The device is manufactured by Jiangsu KeyGEN BioTECH Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is HUMISS COMPANY LIMITED.

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