United Kingdom MHRA device registration 193496

Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay

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

Registration details

Device ID: 193496
MHRA Reference Number: 193496
Date Registered: Nov 26, 2024
Last Updated: Mar 23, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
Type: IVD General

Manufacturer

Name: Assure Tech. (Hangzhou) Co., Ltd.,
Address: Building 4, No 1418-50 Moganshan Road Gongshu District
Zheijiang, Hangzhou, China
Created Date: May 12, 2022

Authorized Representative

Name: Medimap Ltd
Relationship Type: UK Responsible Person
Address: 2 The Drift
Thurston, Suffolk, United Kingdom
Postcode: IP31 3RT

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About this record

Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 193496. The device is manufactured by Assure Tech. (Hangzhou) Co., Ltd., from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Medimap Ltd.

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