Oral/upper respiratory tract specimen collection kit IVD, home-use - UK MHRA Medical Device Registration
Oral/upper respiratory tract specimen collection kit IVD, home-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 168718. The device is manufactured by ACON Biotech (Hangzhou) Co Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Medimap 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
Oral/upper respiratory tract specimen collection kit IVD, home-use
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Mar 23, 2024
Address
No 210 Zhenzhong Road West Lake District
Hangzhou, China
Created Date
Jan 25, 2021
Name
Medimap LtdRelationship Type
Address
2 The Drift
Thurston, Suffolk, United Kingdom
Postcode: IP31 3RT
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.
Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Dengue virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
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
Monkeypox virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple Orthopoxvirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd
Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd
Thermal cycler nucleic acid amplification instrument IVD, manual
Type: In Vitro Diagnostic Device
Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd
Treponema pallidum nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd
Intraoral camera
Type: General Medical Device
Manufacturer: Guilin Kevin Peter Technology Co Ltd
Eye splash shield, single-use
Type: General Medical Device
Manufacturer: Guilin Refine Medical Instrument Co Ltd
Face splash shield, single-use
Type: General Medical Device
Manufacturer: Guilin Refine Medical Instrument Co Ltd
Ultrasonic dental scaling/debridement system
Type: General Medical Device
Manufacturer: Guilin Refine Medical Instrument Co Ltd
Tendon/ligament bone anchor, non-bioabsorbable
Type: General Medical Device
Manufacturer: T.A.G Medical Products Corporation Ltd

