United Kingdom MHRA device registration 189010

Glycated haemoglobin (HbA1c) IVD, control

United Kingdom·In Vitro Diagnostic Device·Abbott Diagnostics Technologies AS·Registered Nov 26, 2024

Registration details

Device ID: 189010
MHRA Reference Number: 189010
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Glycated haemoglobin (HbA1c) IVD, control
Type: Class C

Manufacturer

Name: Abbott Diagnostics Technologies AS
Address: Kjelsasveien 161 P.O. Box 6863 Rodelokka
Oslo, Norway
Created Date: Jul 21, 2021

Authorized Representative

Name: Unipath Limited (trading as Alere International)
Relationship Type: UK Responsible Person
Address: Abbott House Vanwall Road Vanwall Business Park
Maidenhead, Windsor And Maidenhead, England, United Kingdom
Postcode: SL6 4XE

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About this record

Glycated haemoglobin (HbA1c) IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 189010. The device is manufactured by Abbott Diagnostics Technologies AS from Norway, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

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