Specimen processing instrument IVD - UK MHRA Medical Device Registration

Specimen processing instrument IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 148468. The device is manufactured by Beckman Coulter Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Beckman Coulter 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

🇬🇧

Specimen processing instrument IVD

MHRA Device ID: 148468•Ref: 148468

Device Type

In Vitro Diagnostic Device

Devices

Specimen processing instrument IVD

Type

Class A

Date Registered

Nov 26, 2024

Last Updated

Aug 29, 2024

Manufacturer Information

Name

Beckman Coulter Inc.

Address

250 South Kraemer Boulevard

Brea, California, United States

Created Date

Apr 29, 2021

Authorized Representative

Name

Beckman Coulter UK Ltd

Relationship Type

UK Responsible Person

Address

Oakley Court Kingsmead Busines sPark London Rd

High Wycombe, Bucks, United Kingdom

Postcode: HP11 1JU

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Beckman Coulter Inc. (10)

Other Products from Same Authorized Representative (10)

Specimen processing instrument 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

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Hepatitis B virus surface total antibody IVD, calibrator

Hepatitis B virus surface total antibody IVD, control

Creatinine IVD, kit, spectrophotometry

Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Complement factor B IVD, reagent

Chromogen indicator IVD, kit, spectrophotometry

Cannabinoid/cannabinoid metabolite IVD, calibrator

Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Lipoprotein A IVD, calibrator

Flow cytometry analyser IVD

Haematological cell analyser IVD

Specimen processing instrument IVD

Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Flow cytometry analyser IVD, semi-automated

Full blood count IVD, calibrator

General specimen container IVD, no additive/medium

General specimen container IVD, no additive/medium

Digitoxin therapeutic drug monitoring IVD, calibrator

Laboratory instrument/analyser application software IVD