SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 169757. The device is manufactured by Sejoy Biomedical Co.,Ltd. from China, 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.
Device Type
In Vitro Diagnostic Device
Devices
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Feb 22, 2024
Address
Area C, Building 2, NO.365, Wuzhou Road, Yuhang Economic Development Zone
Hangzhou City, Zhejiang Province, China
Created Date
Mar 31, 2023
Name
Obelis UK LtdRelationship Type
Address
Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB
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.
Total cortisol IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Boditech Med Inc.
Prothrombin time (PT) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Universal Biosensors Pty Ltd
Dental casting wax
Type: General Medical Device
Manufacturer: YAMAHACHI DENTAL MFG., CO.
External defibrillation electrode, adult, single-use
Type: General Medical Device
Manufacturer: Progetti S.r.l
Joint prosthesis implantation kit, reusable
Type: General Medical Device
Manufacturer: Aptis Medical LLC
Joint prosthesis implantation kit, reusable
Type: General Medical Device
Manufacturer: Aptis Medical LLC
Cardiology information system application software
Type: General Medical Device
Manufacturer: Implicity
Dental casting wax
Type: General Medical Device
Manufacturer: YAMAHACHI DENTAL MFG., CO.
Physiologic-monitoring defibrillation system
Type: General Medical Device
Manufacturer: Progetti S.r.l
Bedrail
Type: General Medical Device
Manufacturer: Human Care HC AB

