SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 70478. The device is manufactured by Jiangsu Swirl Medical Technology Co., LTD from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath Limited.

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

MHRA Device ID: 70478•Ref: 70478

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jan 23, 2024

Manufacturer Information

Name

Jiangsu Swirl Medical Technology Co., LTD

Address

2F, Building 1, Electronic Industrial Park, No.9 Xindong Road, Economic and Technological Development Zone

Nantong, Jiangsu Province, China

Created Date

Mar 25, 2021

Authorized Representative

Name

MedPath Limited

Relationship Type

UK Responsible Person

Address

27 Old Gloucester Street

London, England, United Kingdom

Postcode: WC1N 3AX

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Same Authorized Representative (10)

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody 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

Gastrostomy tube

Centralized patient monitor

Blood pressure ambulatory recorder

Electrocardiograph, professional, multichannel

Foetal Doppler system

Infrared patient thermometer, skin

Pulse oximeter

Dermatological diode laser system

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nitrile examination/treatment glove, non-powdered, non-antimicrobial