United Kingdom MHRA device registration 155441

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

United Kingdom·In Vitro Diagnostic Device·BioDetect (Xiamen) Biotechnology Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 155441
MHRA Reference Number: 155441
Date Registered: Nov 26, 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: 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

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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 155441. 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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