United Kingdom MHRA device registration 139430

Total alkaline phosphatase (ALP) IVD, reagent

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

Registration details

Device ID: 139430
MHRA Reference Number: 139430
Date Registered: Nov 26, 2024
Last Updated: Oct 5, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Total alkaline phosphatase (ALP) 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 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

Inorganic phosphate (PO43-) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 139448

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 human platelet antigen (HPA) typing IVD, kit, multiplexNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor GTI Diagnostics, Inc.

Device ID: 92337

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Diagnostics for the Real World Ltd

Device ID: 173757

HLA class I antigen tissue typing IVD, kit, multiplexNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor GTI Diagnostics, Inc.

Device ID: 92331

Influenza A/B virus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Asan Pharmaceutical Co., Ltd.

Device ID: 151296

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Asan Pharmaceutical Co., Ltd.

Device ID: 151298

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor GTI Diagnostics, Inc.

Device ID: 92330

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Diagnostics for the Real World Ltd

Device ID: 155028

Glucose IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: MiCo BioMed Co., Ltd.

Device ID: 87952

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor GTI Diagnostics, Inc.

Device ID: 92335

About this record

Total alkaline phosphatase (ALP) IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 139430. 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