United Kingdom MHRA device registration 137821

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

United Kingdom·In Vitro Diagnostic Device·Polymer Technology Systems, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 137821
MHRA Reference Number: 137821
Date Registered: Nov 26, 2024
Last Updated: Oct 10, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
Type: IVD Devices for Self-Testing

Manufacturer

Name: Polymer Technology Systems, Inc.
Address: 4600 Anson Boulevard
Whitestown, IN, United States
Created Date: Feb 23, 2022

Authorized Representative

Name: MDSS-UK RP LIMITED
Relationship Type: UK Responsible Person
Address: 6 Wilmslow Road, Rusholme
Manchester, England, United Kingdom
Postcode: M14 5TP

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About this record

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 137821. The device is manufactured by Polymer Technology Systems, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MDSS-UK RP LIMITED.

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