United Kingdom MHRA device registration 155327

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

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

Registration details

Device ID: 155327
MHRA Reference Number: 155327
Date Registered: Nov 26, 2024
Last Updated: Oct 8, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Monkeypox virus antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Hangzhou Yanyang Biotech Co., Ltd
Address: No. 499 Hongcan Road, HongkenNongchang, Xiaoshan District, Hangzhou
Zhejiang Province, China
Created Date: Jun 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

Monkeypox virus 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 155327. The device is manufactured by Hangzhou Yanyang Biotech 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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