Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Cancer-related multiple gene mutation/mRNA expression 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 132211. 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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Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 132211•Ref: 132211

Device Type

In Vitro Diagnostic Device

Devices

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 8, 2023

Manufacturer Information

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

DJ Fang

MedTech Regulatory Expert

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Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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DJ Fang

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