United Kingdom MHRA device registration 82136

SARS-CoV-2 total antibody IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Hangzhou Sino-Europe Biomedical Science Park Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 82136
MHRA Reference Number: 82136
Date Registered: Nov 26, 2024
Last Updated: Mar 1, 2024

Device classification

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

Manufacturer

Name: Hangzhou Sino-Europe Biomedical Science Park Co., Ltd.
Address: No.9 Jiankang Road, Chengnan street, Tonglu County,
Hangzhou City, Zhejiang Province, China
Created Date: May 24, 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 Hangzhou Sino-Europe Biomedical Science Park Co., Ltd.

Additional devices registered by the same manufacturer

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

Type: In Vitro Diagnostic Device

Device ID: 82135

Other products from same authorized representative

Additional devices represented by NPZ technology Ltd in the UK

Nucleic acid sample preparation instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Wuxi Techstar Technology Co.,Ltd

Device ID: 132017

Endoscopic bite block, basic, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Health Microport Medical Device Co., Ltd.

Device ID: 153246

Flexible endoscopic biopsy forceps, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Health Microport Medical Device Co., Ltd.

Device ID: 173473

Oesophageal bougie, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Health Microport Medical Device Co., Ltd.

Device ID: 153247

First aid absorbent pad/bandageNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Major Medical Products Co., LTD

Device ID: 113343

Skin-cover adhesive strip, non-antimicrobialNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Major Medical Products Co., LTD

Device ID: 201306

Synthetic polymer semi-permeable film dressing, adhesiveNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Major Medical Products Co., LTD

Device ID: 201307

Dental digital imaging sensor, intraoralNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.,

Device ID: 201733

Dental power tool system handpiece, battery-poweredNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.,

Device ID: 86830

Laboratory container/microscope slide robotic transfer system IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Wuxi Techstar Technology Co.,Ltd

Device ID: 132020

About this record

SARS-CoV-2 total 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 82136. The device is manufactured by Hangzhou Sino-Europe Biomedical Science Park 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