United Kingdom MHRA device registration 161869

Heart valve repair/prosthesis implantation kit

United Kingdom·System or Procedure Pack·Edwards Lifesciences LLC·Registered Nov 26, 2024

Registration details

Device ID: 161869
MHRA Reference Number: 161869
Date Registered: Nov 26, 2024
Last Updated: Jan 19, 2024

Device classification

Device Type: System or Procedure Pack
Devices: Heart valve repair/prosthesis implantation kit
Type: System or Procedure Pack

Manufacturer

Name: Edwards Lifesciences LLC
Address: One Edwards Way
Irvine, California, United States
Created Date: Apr 1, 2021

Authorized Representative

Name: Edwards Lifesciences Ltd
Relationship Type: UK Responsible Person
Address: 3, The Sector, Newbury Business Park
Newbury, Berkshire, England, United Kingdom
Postcode: RG14 2PZ

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About this record

Heart valve repair/prosthesis implantation kit is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 161869. The device is manufactured by Edwards Lifesciences LLC from United States, classified as System or Procedure Pack. The authorized representative in the UK is Edwards Lifesciences Ltd.

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