Fluorescent immunoassay analyser IVD, point-of-care - UK MHRA Medical Device Registration
Fluorescent immunoassay analyser IVD, point-of-care is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 164037. The device is manufactured by Shenzhen Uni-medica Technology Co. Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is CMC Medical Devices 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
Fluorescent immunoassay analyser IVD, point-of-care
Type
Class A
Date Registered
Jul 1, 2024
Last Updated
Oct 4, 2023
Address
Room 202, Block 6th, LiuXian Culture Park, XiLi Town, NanShan District,
Shenzhen, Guangdong Province, China
Created Date
Aug 5, 2022
Relationship Type
Address
Office 32 19-21 Crawford Street
London, United Kingdom
Postcode: W1H 1PJ
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.
Glycated haemoglobin (HbA1c) IVD, kit, fluorescent immunoassay, rapid
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Influenza A virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Listeria monocytogenes nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Multiple cardiac marker IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Jul 1, 2024
Adiponectin IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Alpha-fetoprotein (AFP) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Radiation shielding panel, fixed
Type: General Medical Device
Manufacturer: Mavig GmbH
25-Hydroxy vitamin D3 IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Aldosterone IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Operating room light system
Type: System or Procedure Pack
Manufacturer: Mavig GmbH
Radiation shielding collar
Type: General Medical Device
Manufacturer: Mavig GmbH
Radiation shielding panel, fixed
Type: System or Procedure Pack
Manufacturer: Mavig GmbH
Anti-Mullerian hormone (AMH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.

