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

Glycated haemoglobin (HbA1c) IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 100881. The device is manufactured by OSANG Healthcare Co., Ltd. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Obelis UK 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, control

MHRA Device ID: 100881•Ref: 100881

Device Type

In Vitro Diagnostic Device

Devices

Glycated haemoglobin (HbA1c) IVD, control

Type

IVD General

Date Registered

Sep 23, 2024

Last Updated

Jan 23, 2024

Manufacturer Information

Name

OSANG Healthcare Co., Ltd.

Address

132, Anyangcheondong-ro, Dongan-gu,

Anyang-si, Gyeonggi-do, South Korea

Created Date

Aug 30, 2021

Authorized Representative

Name

Obelis UK Ltd

Relationship Type

UK Responsible Person

Address

Sandford Gate, East Point Business Park

Oxford , England, United Kingdom

Postcode: OX4 6LB

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from OSANG Healthcare Co., Ltd. (10)

Other Products from Same Authorized Representative (10)

Glycated haemoglobin (HbA1c) IVD, control - 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

Glucose IVD, reagent

Glucose monitoring system IVD, home-use

Glucose IVD, control

Glucose monitoring system IVD, home-use

Glycated haemoglobin (HbA1c) IVD, reagent

Glycated haemoglobin (HbA1c) IVD, calibrator

Glucose IVD, reagent

Glycated haemoglobin (HbA1C) analyser IVD

Glycated haemoglobin (HbA1c) IVD, calibrator

Glucose IVD, control

Total cortisol IVD, reagent

Prothrombin time (PT) IVD, reagent

Multiple autoimmune disease-associated antibody screening IVD, kit, fluorescent immunoassay

Bed extension

SARS-CoV-2 total/neutralizing antibody IVD, kit, rapid ICT, clinical

Cell morphology analyser IVD, automated/semi-automated

Cell morphology analyser IVD, automated/semi-automated

Multiple stroke (cerebral vascular accident) marker IVD, kit, fluorescent immunoassay

Bed head/footboard

Cardiology information system application software