Carcinoembryonic antigen (CEA) IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Carcinoembryonic antigen (CEA) IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 146120. The device is manufactured by NewScen Coast Bio-Pharmaceutical Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang 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

🇬🇧

Carcinoembryonic antigen (CEA) IVD, kit, rapid ICT, clinical

MHRA Device ID: 146120•Ref: 146120

Device Type

In Vitro Diagnostic Device

Devices

Carcinoembryonic antigen (CEA) IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

May 26, 2024

Manufacturer Information

Name

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Address

No. 65, 6th Street, Tianjin TEDA,

Tianjin, China

Created Date

Sep 18, 2020

Authorized Representative

Name

Wellkang Ltd

Relationship Type

Authorised Representative (Northern Ireland)

Address

Enterprise Hub, NW Business Complex 1 Beraghmore Road

Derry, Northern Ireland, Northern Ireland, United Kingdom

Postcode: BT48 8SE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from NewScen Coast Bio-Pharmaceutical Co., Ltd. (10)

Other Products from Same Authorized Representative (10)

Carcinoembryonic antigen (CEA) 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

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

Faecal occult blood IVD, kit, rapid ICT, self-testing

Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical

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

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Total human chorionic gonadotropin IVD, reagent

Alpha-fetoprotein (AFP) IVD, kit, rapid ICT, clinical

Buffered sample diluent IVD, manual

D-dimer IVD, kit, rapid ICT, clinical

Ferritin IVD, kit, rapid ICT, self-testing

Multiple anti-neutrophil cytoplasmic antibody/glomerular basement membrane antibody IVD, kit, fluorescent immunoassay

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

SARS-CoV-2/influenza A/B antigen IVD, kit, immunochromatographic test (ICT), rapid

Cancer antigen 125 (CA125) IVD, control

Fibrinogen assay (factor I) IVD, control

Glucose IVD, control

Multiple anaemia-related analyte IVD, control

Multiple human hormone IVD, control

Multiple urine analyte IVD, control

Plasma protein IVD, control

General specimen container IVD, no additive/medium