Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care - UK MHRA Medical Device Registration

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 200134. 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

🇬🇧

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

MHRA Device ID: 200134•Ref: 200134

Device Type

In Vitro Diagnostic Device

Devices

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

Type

Class A

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)

Fluorescent immunoassay/spectrophotometry analyser 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

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay

Total cortisol IVD, reagent

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Mycobacterium tuberculosis complex 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

Neutrophil gelatinase-associated lipocalin (NGAL) 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

Glycated haemoglobin (HbA1c) IVD, reagent

Metabolic profile clinical chemistry analyser IVD

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Laparoscopic motorized instrument control unit

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Electrocardiographic lead set, reusable

Anaesthesia breathing circuit, single-use

Carbon dioxide absorbent cartridge

Carbon dioxide absorber, single-use

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

Electrocardiographic lead set, single-use

Electrocardiographic lead switching adaptor

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical