United Kingdom MHRA device registration 125197

Multiple vector-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

United Kingdom·In Vitro Diagnostic Device·SD Biosensor, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 125197
MHRA Reference Number: 125197
Date Registered: Nov 26, 2024
Last Updated: Jun 22, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple vector-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
Type: IVD General

Manufacturer

Name: SD Biosensor, Inc.
Address: C-4th&5th, 16 Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, Republic of Korea
Suwon-si, South Korea
Created Date: May 11, 2021

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

Multiple vector-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125197. The device is manufactured by SD Biosensor, Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting Ltd.

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