Monkeypox virus antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Monkeypox virus 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 155333. The device is manufactured by Beijing Hotgen Biotech 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.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

MHRA Device ID: 155333

Device Type

In Vitro Diagnostic Device

Devices

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Feb 26, 2021

Last Updated

Dec 22, 2022

Manufacturer Information

Name

Beijing Hotgen Biotech Co Ltd

Address

9th Building, No 9 Tianfu Street, Biomedical Base Daxing District

Beijing, China

Created Date

Feb 26, 2021

Authorized Representative

Name

Medimap Ltd

Relationship Type

UK Responsible Person

Address

2 The Drift

Thurston, Suffolk, United Kingdom

Postcode: IP31 3RT

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Beijing Hotgen Biotech Co Ltd (4)

Other Products from Same Authorized Representative (10)

Monkeypox virus antigen IVD, kit, rapid ICT, clinical - 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

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

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay

SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical

Glucose IVD, control

Glucose/haemoglobin (Hb) IVD, reagent

Total cholesterol lipid IVD, control

Cardiac catheterization laboratory computer

Intravascular ultrasound imaging catheter, single-use

Electronic stethoscope

Multi-purpose digital medical camera

Otoscope, direct

Vascular irrigation cannula, coronary artery, reusable

Diamond dental bur, reusable