United Kingdom MHRA device registration 169533

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Zhejiang Orient Gene Biotech Co. Ltd·Registered Nov 26, 2024

Registration details

Device ID: 169533
MHRA Reference Number: 169533
Date Registered: Nov 26, 2024
Last Updated: Jul 25, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Zhejiang Orient Gene Biotech Co. Ltd
Address: 3787#, East Yangguang Avenue, Dipu Street Anji, Huzhou
Zhejiang, China
Created Date: Aug 20, 2021

Authorized Representative

Name: SENSUS Group Ltd
Relationship Type: UK Responsible Person
Address: The Barn Tednambury Farm Tednambury
Spellbrook, Hertfordshire, England, United Kingdom
Postcode: CM23 4BD

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About this record

Beta-haemolytic Group A Streptococcus 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 169533. The device is manufactured by Zhejiang Orient Gene Biotech Co. Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SENSUS Group Ltd.

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