Glycated haemoglobin (HbA1c) monitoring system IVD, home-use - UK MHRA Medical Device Registration

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

MHRA Device ID: 137821•Ref: 137821

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD Devices for Self-Testing

Date Registered

Nov 26, 2024

Last Updated

Oct 10, 2023

Manufacturer Information

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

DJ Fang

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Glycated haemoglobin (HbA1c) monitoring system IVD, home-use - UK MHRA Medical Device Registration

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