United Kingdom MHRA device registration 156237

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·ETest (Nantong) Medical Electronic Technology CO., Ltd·Registered Nov 26, 2024

Registration details

Device ID: 156237
MHRA Reference Number: 156237
Date Registered: Nov 26, 2024
Last Updated: Oct 8, 2023

Device classification

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

Manufacturer

Name: ETest (Nantong) Medical Electronic Technology CO., Ltd
Address: Room 502, Building 9, No.1, Hengke Road, Qutang Town, Haian City
Jiangsu Province, China
Created Date: Sep 15, 2022

Authorized Representative

Name: SUNGO Certification Company Limited
Relationship Type: UK Responsible Person
Address: 3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR

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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 156237. The device is manufactured by ETest (Nantong) Medical Electronic Technology CO., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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