United Kingdom MHRA device registration 140418

Blood gas analyser IVD, laboratory, semi-automated

United Kingdom·In Vitro Diagnostic Device·OPTI Medical Systems, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 140418
MHRA Reference Number: 140418
Date Registered: Nov 26, 2024
Last Updated: Oct 5, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Blood gas analyser IVD, laboratory, semi-automated
Type: IVD General

Manufacturer

Name: OPTI Medical Systems, Inc.
Address: 235 Hembree Park Drive
Roswell, GA, United States
Created Date: Mar 18, 2022

Authorized Representative

Name: MT Promedt Consulting Ltd
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

Blood gas analyser IVD, laboratory, semi-automated is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 140418. The device is manufactured by OPTI Medical Systems, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting Ltd.

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