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 154859. The device is manufactured by ZhiDeMingChuang Biotechnology (Wuxi) 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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Monkeypox virus antigen IVD, kit, rapid ICT, clinical

MHRA Device ID: 154859•Ref: 154859

Device Type

In Vitro Diagnostic Device

Devices

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 19, 2024

Last Updated

Oct 8, 2023

Manufacturer Information

Name

ZhiDeMingChuang Biotechnology (Wuxi) Co., Ltd.

Address

Room 201, Building C, Xingye Building, No. 97-1, Linghu Avenue, Xinwu District, Wuxi

Jiangsu Province, China

Created Date

Aug 22, 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 ZhiDeMingChuang Biotechnology (Wuxi) Co., Ltd. (1)

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

Type: In Vitro Diagnostic Device

Registered: Nov 19, 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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