Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care - UK MHRA Medical Device Registration

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 137820. 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.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

MHRA Device ID: 137820•Ref: 137820

Device Type

In Vitro Diagnostic Device

Devices

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

Type

IVD General

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

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Polymer Technology Systems, Inc. (10)

Other Products from Same Authorized Representative (10)

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Triglyceride IVD, kit, rapid colorimetric, clinical

Multiple lipid analyte IVD, kit, rapid colorimetric, clinical

Multiple clinical chemistry analyser IVD, home-use

Glucose monitoring system IVD, point-of-care

Total cholesterol lipid IVD, kit, rapid colorimetric, clinical

Multiple lipid analyte IVD, kit, multiple technologies

Multiple-type clinical chemistry analyte profile IVD, control

Glucose IVD, kit, enzyme spectrophotometry, rapid

Multiple clinical chemistry analyser IVD, point-of-care

Multiple lipid analyte IVD, kit, enzyme spectrophotometry

Abdominal binder, reusable

Cast shoe, reusable

Wheelchair head/trunk support, prefabricated

Wheelchair handrim

Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Wheelchair bracket

Glucose monitoring system IVD, home-use

Wheelchair brakes

Clavicle orthosis