United Kingdom MHRA device registration 134332

Coagulation factor XIII IVD, reagent

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·KAMIYA BIOMEDICAL COMPANY, LLC·Registered Nov 26, 2024
Registration details
Device ID
134332
MHRA Reference Number
134332
Date Registered
Nov 26, 2024
Last Updated
Mar 6, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Coagulation factor XIII IVD, reagent
Type
IVD General
Manufacturer
Address
12779 Gateway Drive S.
Tukwila, WA, United States
Created Date
Dec 23, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
184B Park Drive Milton Park Abingdon
Abingdon, Oxfordshire, United Kingdom
Postcode: OX14 4SE
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About this record

Coagulation factor XIII IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 134332. The device is manufactured by KAMIYA BIOMEDICAL COMPANY, LLC from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Oxford Biosystems Ltd.

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