SARS-CoV-2 total antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

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

MHRA Device ID: 82136•Ref: 82136

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Mar 1, 2024

Manufacturer Information

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

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Hangzhou Sino-Europe Biomedical Science Park Co., Ltd. (1)

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

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Other Products from Same Authorized Representative (10)

SARS-CoV-2 total 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

Rotavirus antigen IVD, kit, rapid ICT, clinical

Troponin T IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Prolactin IVD, kit, fluorescent immunoassay

Total triiodothyronine (TT3) IVD, kit, fluorescent immunoassay

Troponin I IVD, kit, fluorescent immunoassay

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

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

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

Glucose IVD, reagent

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

Basic light microscope IVD

Limb immobilization/support skin adhesive tape

Pressure bandage, non-latex, single-use

Basic intravenous administration set, noninvasive

Electronic gravity infusion controller administration set

Analgesic transcutaneous electrical nerve stimulation system

Multiple allergen-specific immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Glucose IVD, control