United Kingdom MHRA device registration 139449

Total bilirubin IVD, reagent

United Kingdom·In Vitro Diagnostic Device· SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH·Registered Nov 26, 2024

Registration details

Device ID: 139449
MHRA Reference Number: 139449
Date Registered: Nov 26, 2024
Last Updated: Oct 5, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Total bilirubin IVD, reagent
Type: IVD General

Manufacturer

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

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Additional devices registered by the same manufacturer

Lipase IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139446

Total alkaline phosphatase (ALP) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139430

Total amylase IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139433

Creatinine IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139438

C-reactive protein (CRP) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139439

Calcium (Ca2+) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139435

Conjugated (direct) bilirubin IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139440

Gamma-glutamyltransferase (GGT) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139441

Glucose IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139442

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-careNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139454

Other products from same authorized representative

Additional devices represented by MT Promedt Consulting Ltd in the UK

Laparoscopic motorized instrument control unit

Type: General Medical Device

Manufacturer: American Orthodontics Corp

Device ID: 175758

Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: i-SENS, Inc.

Device ID: 111553

Glucose IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: i-SENS, Inc.

Device ID: 198049

Haptoglobin IVD, kit, precipitation/immunodiffusionNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: INEX Innovate Pte Ltd

Device ID: 168073

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-careNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: i-SENS, Inc.

Device ID: 111554

Glucose IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: i-SENS, Inc.

Device ID: 198050

Metabolic profile clinical chemistry analyser IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: i-SENS, Inc.

Device ID: 111559

Glucose monitoring system IVD, home-useNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: i-SENS, Inc.

Device ID: 198048

Manual blood lancing device, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: i-SENS, Inc.

Device ID: 92455

Multiple clinical chemistry analyte monitoring system IVD, home-useNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: i-SENS, Inc.

Device ID: 198051

About this record

Total bilirubin IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 139449. 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device