United Kingdom MHRA device registration 139437

Total creatine kinase (CK) IVD, reagent

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

Registration details

Device ID: 139437
MHRA Reference Number: 139437
Date Registered: Nov 26, 2024
Last Updated: Oct 5, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Total creatine kinase (CK) 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

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About this record

Total creatine kinase (CK) IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 139437. 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.

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