United Kingdom MHRA device registration 122412

Nucleic acid extraction/isolation kit IVD

United Kingdom·In Vitro Diagnostic Device·ALPHAGENE Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 122412
MHRA Reference Number: 122412
Date Registered: Nov 26, 2024
Last Updated: Nov 29, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Nucleic acid extraction/isolation kit IVD
Type: IVD General

Manufacturer

Name: ALPHAGENE Co., Ltd.
Address: #109, #301 B-dong, 531, Dunchon-daero, Jungwon-gu
Seongnam-si, Gyeonggi-do, South Korea
Created Date: Dec 16, 2021

Authorized Representative

Name: CMC Medical Devices LTD
Relationship Type: UK Responsible Person
Address: Office 32 19-21 Crawford Street
London, United Kingdom
Postcode: W1H 1PJ

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About this record

Nucleic acid extraction/isolation kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 122412. The device is manufactured by ALPHAGENE Co., Ltd. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is CMC Medical Devices LTD.

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