United Kingdom MHRA device registration 74676

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Wuhan UNscience Biotechnology Co., Ltd·Registered Nov 19, 2024

Registration details

Device ID: 74676
MHRA Reference Number: 74676
Date Registered: Nov 19, 2024
Last Updated: Jan 23, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Wuhan UNscience Biotechnology Co., Ltd
Address: Building B18, 2nd Phase of Biomedical Park, #858 GaoXin Road, Donghu Hi-Tech Development
Wuhan, Hubei, China
Created Date: Apr 21, 2021

Authorized Representative

Name: NPZ technology Ltd
Relationship Type: UK Responsible Person
Address: Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach
Cambridge, Cambridgeshire, United Kingdom
Postcode: CB25 9QE

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 NPZ technology Ltd in the UK

Glucose IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Yasee Biomedical Inc.

Device ID: 193895

Glucose IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Yasee Biomedical Inc.

Device ID: 193896

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beijing BGI-GBI Biotech Co., Ltd.

Device ID: 83416

Basic light microscope IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Cision Vision, Inc.

Device ID: 194685

Limb immobilization/support skin adhesive tapeNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Yoniner Pharmaceutical Co., Ltd

Device ID: 160303

Pressure bandage, non-latex, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Hangzhou Yoniner Pharmaceutical Co., Ltd

Device ID: 160302

Basic intravenous administration set, noninvasiveNov 26, 2024

Type: General Medical Device

Manufacturer: Hanscent （Ningbo） Co., Ltd.

Device ID: 190352

Electronic gravity infusion controller administration setNov 26, 2024

Type: General Medical Device

Manufacturer: Hanscent （Ningbo） Co., Ltd.

Device ID: 80051

Analgesic transcutaneous electrical nerve stimulation systemNov 26, 2024

Type: General Medical Device

Manufacturer: Cathay Manufacturing Corp

Device ID: 161868

Open-surgery electrosurgical handpiece/electrode, monopolar, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Cathay Manufacturing Corp

Device ID: 64114

About this record

SARS-CoV-2 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 74676. The device is manufactured by Wuhan UNscience Biotechnology Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device