United Kingdom MHRA device registration 155582

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

United Kingdom·In Vitro Diagnostic Device·Sanway Gene Tech. Inc.·Registered Nov 26, 2024

Registration details

Device ID: 155582
MHRA Reference Number: 155582
Date Registered: Nov 26, 2024
Last Updated: Jan 23, 2024

Device classification

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

Manufacturer

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

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About this record

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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