Multiplex analyser IVD, laboratory - UK MHRA Medical Device Registration
Multiplex analyser IVD, laboratory is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 178927. The device is manufactured by Sugentech, 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.
Device Type
In Vitro Diagnostic Device
Devices
Multiplex analyser IVD, laboratory
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Oct 22, 2024
Name
Sugentech, Inc.Address
721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu
Cheongju-si, Chungcheongbuk-do, South Korea
Created Date
Jun 29, 2021
Relationship Type
Address
Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Photometric/spectroscopic immunoassay analyser IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Laparoscopic motorized instrument control unit
Type: General Medical Device
Manufacturer: American Orthodontics Corp
Hypodermic needle, single-use
Type: General Medical Device
Manufacturer: Henke-Sass, Wolf GmbH
Anti-B red blood cell grouping IVD, antibody
Type: In Vitro Diagnostic Device
Manufacturer: Dominion Biologicals Limited
Haematological cell analyser IVD
Type: In Vitro Diagnostic Device
Manufacturer: NanoEnTek Inc.
Microscope counting chamber IVD
Type: In Vitro Diagnostic Device
Manufacturer: NanoEnTek Inc.
Anti-A red blood cell grouping IVD, antibody
Type: In Vitro Diagnostic Device
Manufacturer: Dominion Biologicals Limited
Rigid optical hysteroscope
Type: General Medical Device
Manufacturer: Henke-Sass, Wolf GmbH
Anti-C [RH002] red blood cell grouping IVD, antibody
Type: In Vitro Diagnostic Device
Manufacturer: Dominion Biologicals Limited
Anti-C [RH004] red blood cell grouping IVD, antibody
Type: In Vitro Diagnostic Device
Manufacturer: Dominion Biologicals Limited
General-purpose syringe, reusable
Type: General Medical Device
Manufacturer: Henke-Sass, Wolf GmbH

