Total bilirubin IVD, kit, spectrophotometry - UK MHRA Medical Device Registration

Total bilirubin IVD, kit, spectrophotometry is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 135785. The device is manufactured by FUJIFILM Wako Chemicals Europe GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Fujifilm Healthcare UK 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

🇬🇧

Total bilirubin IVD, kit, spectrophotometry

MHRA Device ID: 135785•Ref: 135785

Device Type

In Vitro Diagnostic Device

Devices

Total bilirubin IVD, kit, spectrophotometry

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 20, 2024

Manufacturer Information

Name

FUJIFILM Wako Chemicals Europe GmbH

Address

Fuggerstr 12

Neuss, Germany

Created Date

Jan 7, 2022

Authorized Representative

Name

Fujifilm Healthcare UK Limited

Relationship Type

UK Responsible Person

Address

Fujifilm House Whitbread Way

Bedford, England, United Kingdom

Postcode: MK42 0ZE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from FUJIFILM Wako Chemicals Europe GmbH (10)

Other Products from Same Authorized Representative (10)

Total bilirubin IVD, kit, spectrophotometry - 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

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

High density lipoprotein (HDL) cholesterol IVD, calibrator

High density lipoprotein (HDL) cholesterol IVD, reagent

Multiple ketone body IVD, kit, enzyme spectrophotometry

Multiple-type clinical chemistry analyte profile IVD, control

Total complement activity (CH50) IVD, calibrator

Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA)

Total/conjugated (direct) bilirubin IVD, calibrator

Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA)

Beta-hydroxybutyrate IVD, calibrator

Albumin IVD, kit, spectrophotometry

C-reactive protein (CRP) IVD, calibrator

Carbon dioxide (CO2) IVD, kit, spectrophotometry

Computed radiography digital imaging scanner

Computed radiography digital imaging scanner

Creatinine IVD, kit, enzyme spectrophotometry

Diagnostic x-ray digital imaging conversion system

Diagnostic x-ray digital imaging system workstation

Diagnostic x-ray system generator, portable

Endoscope flushing adaptor, reusable