United Kingdom MHRA device registration 163696

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·VivaChek Biotech (Hangzhou) Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 163696
MHRA Reference Number: 163696
Date Registered: Nov 26, 2024
Last Updated: Jun 11, 2024

Device classification

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

Manufacturer

Name: VivaChek Biotech (Hangzhou) Co., Ltd.
Address: Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone,
Hangzhou, Zhejiang, China
Created Date: Mar 14, 2021

Authorized Representative

Name: lotus global co ltd
Relationship Type: UK Responsible Person
Address: 23 Maine Street
Reading, Reading, England, United Kingdom
Postcode: RG2 6AG

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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 163696. The device is manufactured by VivaChek Biotech (Hangzhou) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is lotus global co ltd.

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