United Kingdom MHRA device registration 125189

Multiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

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

Registration details

Device ID: 125189
MHRA Reference Number: 125189
Date Registered: Nov 26, 2024
Last Updated: Jun 22, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
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 Leptospira species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125189. 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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