Glycated haemoglobin (HbA1c) IVD, reagent - UK MHRA Medical Device Registration

Glycated haemoglobin (HbA1c) IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 111555. The device is manufactured by i-SENS, Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting Ltd.

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) IVD, reagent

MHRA Device ID: 111555•Ref: 111555

Device Type

In Vitro Diagnostic Device

Devices

Glycated haemoglobin (HbA1c) IVD, reagent

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

May 9, 2024

Manufacturer Information

Name

i-SENS, Inc.

Address

43, Banpo-daero 28-gil, Seocho-gu

Seoul , South Korea

Created Date

Jul 21, 2021

Authorized Representative

Name

MT Promedt Consulting Ltd

Relationship Type

UK Responsible Person

Address

Beaver House, 23-38 Hythe Bridge Street

Oxford, England, United Kingdom

Postcode: OX1 2EP

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from i-SENS, Inc. (10)

Other Products from Same Authorized Representative (10)

Glycated haemoglobin (HbA1c) IVD, reagent - 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

Albumin/creatinine ratio (ACR) IVD, reagent

Glucose monitoring system IVD, home-use

Glycated haemoglobin (HbA1c) IVD, control

Ketone (acetoacetate) IVD, control

Ketone (acetoacetate) IVD, reagent

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Albumin/creatinine ratio (ACR) IVD, control

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care

Metabolic profile clinical chemistry analyser IVD

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Laparoscopic motorized instrument control unit

Wash/cleaning solution IVD, automated/semi-automated system

Mechanical stethoscope

Sweat-induction iontophoresis system

Evacuated erythrocyte sedimentation rate (ESR) tube IVD

Cytological centrifuge IVD

Multiple-type clinical chemistry analyte profile IVD, control

Multiple electrolyte IVD, calibrator

Chloride coulometric titration analyser IVD, semi-automated

Sweat-induction iontophoresis system