Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Monkeypox virus immunoglobulin M (IgM) 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 155959. The device is manufactured by New Gene (Hangzhou) Bioengineering 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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In Vitro Diagnostic Device

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Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

MHRA Device ID: 155959•Ref: 155959

Device Type

In Vitro Diagnostic Device

Devices

Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 8, 2023

Manufacturer Information

Name

New Gene (Hangzhou) Bioengineering Co., Ltd.

Address

Room 1606, Floor 16, Building 5, 688 Bin'an Road, Changhe Street, Binjiang District, Hangzhou

Zhejiang Province, China

Created Date

Sep 9, 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

DJ Fang

MedTech Regulatory Expert

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Other Products from New Gene (Hangzhou) Bioengineering Co., Ltd. (2)

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Other Products from Same Authorized Representative (10)

Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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Monkeypox virus antigen IVD, kit, rapid ICT, clinical

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