SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 82805. The device is manufactured by Xiamen Hopegen Medical 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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SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

MHRA Device ID: 82805•Ref: 82805

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 19, 2024

Last Updated

Mar 13, 2024

Manufacturer Information

Name

Xiamen Hopegen Medical Technology Co., Ltd.

Address

Room 905, 253 Duiying Nan Road, Houxi Town Jimei District, Xiamen

Fujian Province, China

Created Date

Mar 26, 2021

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

DJ Fang

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SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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