United Kingdom MHRA device registration 165286

Total amylase IVD, reagent

United Kingdom·In Vitro Diagnostic Device·HORIBA Instruments Incorporated ·Registered Nov 26, 2024

Registration details

Device ID: 165286
MHRA Reference Number: 165286
Date Registered: Nov 26, 2024
Last Updated: Mar 16, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Total amylase IVD, reagent
Type: Class B

Manufacturer

Name: HORIBA Instruments Incorporated
Address: Pointe/Pointe Scientific 5449 Research Drive
Canton, Michigan, United States
Created Date: Jan 23, 2023

Authorized Representative

Name: HORIBA UK Limited
Relationship Type: UK Responsible Person
Address: KYOTO CLOSE MOULTON PARK
NORTHAMPTON, Northants, United Kingdom
Postcode: NN3 6FL

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About this record

Total amylase IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 165286. The device is manufactured by HORIBA Instruments Incorporated from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is HORIBA UK Limited.

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