Conjugated (direct) bilirubin IVD, reagent - UK MHRA Medical Device Registration

Conjugated (direct) bilirubin IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 139440. The device is manufactured by SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH from Taiwan, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting 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

🇬🇧

Conjugated (direct) bilirubin IVD, reagent

MHRA Device ID: 139440•Ref: 139440

Device Type

In Vitro Diagnostic Device

Devices

Conjugated (direct) bilirubin IVD, reagent

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 5, 2023

Manufacturer Information

Name

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Address

1F, No.8, Dusing Rd., Hsinchu Science Park, East Dist.

Hsinchu City, Taiwan

Created Date

Mar 10, 2022

Authorized Representative

Name

MT Promedt Consulting Ltd

Relationship Type

UK Responsible Person

Address

Beaver House, 23-38 Hythe Bridge Street

Oxford, England, United Kingdom

Postcode: OX1 2EP

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH (10)

Other Products from Same Authorized Representative (10)

Conjugated (direct) bilirubin IVD, reagent - 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

Lipase IVD, reagent

Total alkaline phosphatase (ALP) IVD, reagent

Total amylase IVD, reagent

Creatinine IVD, reagent

C-reactive protein (CRP) IVD, reagent

Calcium (Ca2+) IVD, reagent

Gamma-glutamyltransferase (GGT) IVD, reagent

Glucose IVD, reagent

Inorganic phosphate (PO43-) IVD, reagent

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

Laparoscopic motorized instrument control unit

Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Clinical laboratory information system application software

Oral/upper respiratory tract specimen collection kit IVD, clinical

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

HLA class I antigen tissue typing IVD, kit, multiplex

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)