United Kingdom MHRA device registration 4266

Laboratory instrument/analyser application software IVD

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Hologic, Inc.·Registered Nov 26, 2024
Registration details
Device ID
4266
MHRA Reference Number
4266
Date Registered
Nov 26, 2024
Last Updated
Mar 31, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Laboratory instrument/analyser application software IVD
Type
IVD General
Manufacturer
Address
250 Campus Drive
Marlborough, MA, United States
Created Date
Nov 6, 2017
Authorized Representative
Relationship Type
UK Responsible Person
Address
Heron House 6 The Oaks Business Park Crewe Road Wythenshawe
Manchester, Lancashire, England, United Kingdom
Postcode: M23 9HZ
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About this record

Laboratory instrument/analyser application software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 4266. The device is manufactured by Hologic, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Hologic Ltd..

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