United Kingdom MHRA device registration 125145

Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·SD Biosensor, Inc.·Registered Nov 26, 2024
Registration details
Device ID
125145
MHRA Reference Number
125145
Date Registered
Nov 26, 2024
Last Updated
Jun 22, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay
Type
IVD General
Manufacturer
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
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

Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125145. 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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