United Kingdom MHRA device registration 181850

Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Igenesis (Shanghai) Co., Ltd.·Registered Nov 15, 2024

Registration details

Device ID: 181850
MHRA Reference Number: 181850
Date Registered: Nov 15, 2024
Last Updated: Nov 16, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: Igenesis (Shanghai) Co., Ltd.
Address: Floor 3, Building 1, Lane 500, Furonghua Road, Pudong New Area
Shanghai, China
Created Date: Nov 14, 2023

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

Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 181850. The device is manufactured by Igenesis (Shanghai) 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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