United Kingdom MHRA device registration 168042

Aortic bi-leaflet mechanical heart valve prosthesis

United Kingdom·General Medical Device·On-X Life Technologies, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 168042
MHRA Reference Number: 168042
Date Registered: Nov 26, 2024
Last Updated: Apr 16, 2024

Device classification

Device Type: General Medical Device
Devices: Aortic bi-leaflet mechanical heart valve prosthesis
Type: Class III

Manufacturer

Name: On-X Life Technologies, Inc.
Address: 1300 E Anderson Ln
Austin, Texas, United States
Created Date: Mar 8, 2023

Authorized Representative

Name: OMC MEDICAL Ltd
Relationship Type: UK Responsible Person
Address: Planet House North Heath Lane
Horsham, West Sussex, United Kingdom
Postcode: RH12 5QE

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About this record

Aortic bi-leaflet mechanical heart valve prosthesis is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 168042. The device is manufactured by On-X Life Technologies, Inc. from United States, classified as General Medical Device. The authorized representative in the UK is OMC MEDICAL Ltd.

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