United Kingdom MHRA device registration 114517

Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)

United Kingdom·In Vitro Diagnostic Device·Roche Diagnostics GmbH·Registered Nov 26, 2024

Registration details

Device ID: 114517
MHRA Reference Number: 114517
Date Registered: Nov 26, 2024
Last Updated: Oct 10, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
Type: IVD General

Manufacturer

Name: Roche Diagnostics GmbH
Address: Sandhofer Strasse 116
Mannheim, Germany
Created Date: Apr 19, 2021

Authorized Representative

Name: Roche Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Roche Diagnostics Limited Charles Avenue
Burgess Hill, West Sussex, United Kingdom
Postcode: RH15 9RY

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About this record

Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 114517. The device is manufactured by Roche Diagnostics GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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