Prothrombin time (PT) IVD, reagent - UK MHRA Medical Device Registration

Prothrombin time (PT) IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 170250. The device is manufactured by Guangzhou Wondfo Biotech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK 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

🇬🇧

Prothrombin time (PT) IVD, reagent

MHRA Device ID: 170250•Ref: 170250

Device Type

In Vitro Diagnostic Device

Devices

Prothrombin time (PT) IVD, reagent

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jul 31, 2024

Manufacturer Information

Name

Guangzhou Wondfo Biotech Co., Ltd.

Address

No.8 Lizhishan Road, Science City, Huangpu District

Guangzhou, China

Created Date

Mar 7, 2021

Authorized Representative

Name

Qarad UK Ltd.

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Guangzhou Wondfo Biotech Co., Ltd. (10)

Other Products from Same Authorized Representative (10)

Prothrombin time (PT) IVD, reagent - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Legionella pneumophila 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

Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Ultraviolet-visible spectrophotometer IVD

Rheumatoid factor IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Suppression of tumorigenicity 2 (ST2) IVD, kit, fluorescent immunoassay

Vitamin B12 IVD, kit, rapid ICT, clinical

Activated partial thromboplastin time (APTT) IVD, reagent

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA)

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Oral/upper respiratory tract specimen collection kit

Oral/upper respiratory tract specimen collection kit IVD, clinical

Carpal scaphoid prosthesis

Fluted surgical drill bit, reusable

Mobile patient lifting system, electrically-powered

Overhead track patient lifting/transfer system

Patient lifting system stretcher

HIV1/HIV2 antibody IVD, control