Urine analyser IVD, point-of-care - UK MHRA Medical Device Registration

Urine analyser IVD, point-of-care is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 106531. The device is manufactured by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company 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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Urine analyser IVD, point-of-care

MHRA Device ID: 106531•Ref: 106531

Device Type

In Vitro Diagnostic Device

Devices

Urine analyser IVD, point-of-care

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Sep 21, 2024

Manufacturer Information

Name

Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.

Address

No. 8, Shengchang West Road, Danyang Development Zone

Jiangsu Province, China

Created Date

Oct 1, 2021

Authorized Representative

Name

SUNGO Certification Company Limited

Relationship Type

UK Responsible Person

Address

3rd Floor, 70 Gracechurch Street

London, England, United Kingdom

Postcode: EC3V 0HR

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. (10)

Other Products from Same Authorized Representative (10)

Urine analyser IVD, point-of-care - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

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

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

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

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species 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

D-dimer IVD, kit, fluorescent immunoassay

Creatinine IVD, reagent

Glucose IVD, reagent

Haemoglobin analyser IVD, point-of-care

Haemoglobin detection IVD, reagent

Patient monitoring system module, multifunction

Total aspartate aminotransferase (AST) IVD, reagent

Uric acid IVD, reagent

Alanine aminotransferase (ALT) IVD, reagent

Albumin IVD, reagent

Emergency airway clearance suction system, electric

Non-wearable adult urine collection bag, open-ended

Surgical gown, single-use

Airway suction catheter

Indwelling urethral drainage balloon catheter, non-antimicrobial

Surgical cap, single-use

Surgical cap, single-use

Dental impression tray, single-use

Silicone dental impression material

Basic endotracheal tube, single-use

Electric-motor-driven wheelchair, occupant-controlled