HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

HIV1/Hepatitis C virus/Hepatitis B 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 155582. The device is manufactured by Sanway Gene Tech. Inc. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Obelis UK Ltd.

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In Vitro Diagnostic Device

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HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 155582•Ref: 155582

Device Type

In Vitro Diagnostic Device

Devices

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

IVD Annex II List A

Date Registered

Nov 26, 2024

Last Updated

Jan 23, 2024

Manufacturer Information

Name

Sanway Gene Tech. Inc.

Address

No. 680, Lusong Road, Yuelu District

Changsha, Hunan Province, China

Created Date

Sep 2, 2022

Authorized Representative

Name

Obelis UK Ltd

Relationship Type

UK Responsible Person

Address

Sandford Gate, East Point Business Park

Oxford , England, United Kingdom

Postcode: OX4 6LB

DJ Fang

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HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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