United Kingdom MHRA device registration 132212

Human genomic analysis interpretive software IVD

United Kingdom·In Vitro Diagnostic Device·BGI Europe A/S·Registered Nov 26, 2024

Registration details

Device ID: 132212
MHRA Reference Number: 132212
Date Registered: Nov 26, 2024
Last Updated: Oct 8, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Human genomic analysis interpretive software IVD
Type: IVD General

Manufacturer

Name: BGI Europe A/S
Address: Symfonivej 34
Herlev, Denmark
Created Date: Aug 30, 2021

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

Human genomic analysis interpretive software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 132212. The device is manufactured by BGI Europe A/S from Denmark, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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