Chemiluminescent immunoassay analyser IVD - UK MHRA Medical Device Registration

Chemiluminescent immunoassay analyser IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 194605. The device is manufactured by HYCOR Biomedical Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Advena 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

🇬🇧

Chemiluminescent immunoassay analyser IVD

MHRA Device ID: 194605•Ref: 194605

Device Type

In Vitro Diagnostic Device

Devices

Chemiluminescent immunoassay analyser IVD

Type

Class A

Date Registered

Nov 26, 2024

Last Updated

Jun 5, 2024

Manufacturer Information

Name

HYCOR Biomedical Inc.

Address

7272 Chapman Avenue CA 92841 U.S.A.

Garden Grove, CA, United States

Created Date

May 30, 2024

Authorized Representative

Name

Advena Ltd

Relationship Type

UK Responsible Person

Address

Pure Offices Plato Close

Warwick, England, United Kingdom

Postcode: CV34 6WE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from HYCOR Biomedical Inc. (1)

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

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Other Products from Same Authorized Representative (10)

Chemiluminescent immunoassay analyser IVD - 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

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

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Rib/sternum binder, single-use

Colour-indication patient thermometer

Dental suction system cannula, single-use

Hot/cold therapy pack, single-use

Artificial saliva

Nail infection solution

Colour-indication patient thermometer

Medicine cup, single-use

Basic intravenous administration set, noninvasive