United Kingdom MHRA device registration 154860

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

United Kingdom·In Vitro Diagnostic Device·ZhiDeMingChuang Biotechnology (Wuxi) Co., Ltd.·Registered Nov 19, 2024

Registration details

Device ID: 154860
MHRA Reference Number: 154860
Date Registered: Nov 19, 2024
Last Updated: Oct 8, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

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

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About this record

Monkeypox virus nucleic acid 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 154860. 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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