United Kingdom MHRA device registration 70478

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

United Kingdom·In Vitro Diagnostic Device·Jiangsu Swirl Medical Technology Co., LTD·Registered Nov 26, 2024

Registration details

Device ID: 70478
MHRA Reference Number: 70478
Date Registered: Nov 26, 2024
Last Updated: Jan 23, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

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

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

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

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from same authorized representative

Additional devices represented by MedPath Limited in the UK

Catheter/overtube balloon inflator, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Conod Medical Co., Limited

Device ID: 171055

Faecal incontinence collector, catheterizationNov 26, 2024

Type: General Medical Device

Manufacturer: Conod Medical Co., Limited

Device ID: 80254

Wearable adult urine collection bag, open-endedNov 26, 2024

Type: General Medical Device

Manufacturer: Conod Medical Co., Limited

Device ID: 203039

Wearable adult urine collection bag, open-endedNov 26, 2024

Type: System or Procedure Pack

Manufacturer: Conod Medical Co., Limited

Device ID: 176960

Wearable adult urine collection bag, open-endedNov 26, 2024

Type: General Medical Device

Manufacturer: Conod Medical Co., Limited

Device ID: 185491

Nitrile examination/treatment glove, non-powdered, non-antimicrobialNov 26, 2024

Type: General Medical Device

Manufacturer: Jiangsu Bytech Medical Supplies Co.,Ltd.

Device ID: 189858

Vinyl examination/treatment glove, non-powderedNov 26, 2024

Type: General Medical Device

Manufacturer: Jiangsu Cureguard Glove Co., Ltd.

Device ID: 114801

Vinyl examination/treatment glove, non-powderedNov 26, 2024

Type: General Medical Device

Manufacturer: Jiangsu Huayuan Medical Technology Co.,Ltd.

Device ID: 80319

Haemodialysis start/stop setNov 26, 2024

Type: General Medical Device

Manufacturer: Wujiang Kangxin Surgical Dressings Co.,Ltd.

Device ID: 197132

Limb tourniquet, manual, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: MEDPLUS INC.

Device ID: 129555

About this record

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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device