SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing - UK MHRA Medical Device Registration

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 109356. The device is manufactured by Zhejiang Orient Gene Biotech Co. Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SENSUS Group 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

🇬🇧

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

MHRA Device ID: 109356•Ref: 109356

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Type

IVD Devices for Self-Testing

Date Registered

Nov 26, 2024

Last Updated

Jul 25, 2024

Manufacturer Information

Name

Zhejiang Orient Gene Biotech Co. Ltd

Address

3787#, East Yangguang Avenue, Dipu Street Anji, Huzhou

Zhejiang, China

Created Date

Aug 20, 2021

Authorized Representative

Name

SENSUS Group Ltd

Relationship Type

UK Responsible Person

Address

The Barn Tednambury Farm Tednambury

Spellbrook, Hertfordshire, England, United Kingdom

Postcode: CM23 4BD

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Zhejiang Orient Gene Biotech Co. Ltd (10)

Other Products from Same Authorized Representative (10)

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium 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

D-dimer IVD, kit, fluorescent immunoassay

Human metapneumovirus (hMPV) antigen IVD, kit, rapid ICT, clinical

Multiple gastrointestinal disease marker IVD, kit, rapid ICT, clinical

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical

Procalcitonin (PCT) IVD, kit, rapid ICT, clinical

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Rheumatoid factor IVD, kit, rapid ICT, clinical

Multiple Brucella species total antibody IVD, kit, rapid ICT, clinical

Multiple Candida species antigen IVD, kit, rapid ICT, clinical

General-body orifice lubricant

General-body orifice lubricant, non-sterile

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Hepatitis A virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Alpha-fetoprotein (AFP) IVD, kit, rapid ICT, clinical

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

Mpox virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical