Monkeypox virus antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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 155442. The device is manufactured by BioDetect (Xiamen) Biotechnology 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 antigen IVD, kit, rapid ICT, clinical

MHRA Device ID: 155442•Ref: 155442

Device Type

In Vitro Diagnostic Device

Devices

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 8, 2023

Manufacturer Information

Name

BioDetect (Xiamen) Biotechnology Co., Ltd.

Address

Building B9 and B5, Xiamen Biomedical Industrial Park, 2066 Wengjiao West Road, Xiamen

Fujian Province, China

Created Date

Aug 31, 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

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Other Products from BioDetect (Xiamen) Biotechnology Co., Ltd. (1)

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 antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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

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