United Kingdom MHRA device registration 131437

Beta-hydroxybutyrate IVD, kit, enzyme spectrophotometry

United Kingdom·In Vitro Diagnostic Device·FUJIFILM Wako Chemicals Europe GmbH·Registered Nov 26, 2024

Registration details

Device ID: 131437
MHRA Reference Number: 131437
Date Registered: Nov 26, 2024
Last Updated: Nov 20, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Beta-hydroxybutyrate IVD, kit, enzyme spectrophotometry
Type: IVD General

Manufacturer

Name: FUJIFILM Wako Chemicals Europe GmbH
Address: Fuggerstr 12
Neuss, Germany
Created Date: Jan 7, 2022

Authorized Representative

Name: Fujifilm Healthcare UK Limited
Relationship Type: UK Responsible Person
Address: Fujifilm House Whitbread Way
Bedford, England, United Kingdom
Postcode: MK42 0ZE

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About this record

Beta-hydroxybutyrate IVD, kit, enzyme spectrophotometry is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 131437. The device is manufactured by FUJIFILM Wako Chemicals Europe GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Fujifilm Healthcare UK Limited.

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