United Kingdom MHRA device registration 165188

Multiple infectious organism/newborn TORCH screen IVD, kit, rapid ICT, clinical

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Hangzhou Alltest Biotech Co Ltd·Registered Nov 26, 2024
Registration details
Device ID
165188
MHRA Reference Number
165188
Date Registered
Nov 26, 2024
Last Updated
Jun 15, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Multiple infectious organism/newborn TORCH screen IVD, kit, rapid ICT, clinical
Type
IVD Annex II List B
Manufacturer
Address
#550 Yinhai Street Hangzhou Economic & Technological Development Area
Hangzhou, China
Created Date
Mar 9, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
2 The Drift
Thurston, Suffolk, United Kingdom
Postcode: IP31 3RT
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About this record

Multiple infectious organism/newborn TORCH screen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 165188. The device is manufactured by Hangzhou Alltest Biotech Co Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Medimap Ltd.

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