United Kingdom MHRA device registration 119004

Pneumatic/ultrasonic lithotripsy system

United Kingdom·General Medical Device·Gyrus ACMI, Inc.·Registered Jul 23, 2021

Registration details

Device ID: 119004
MHRA Reference Number: 119004
Date Registered: Jul 23, 2021
Last Updated: Jan 4, 2024

Device classification

Device Type: General Medical Device
Devices: Pneumatic/ultrasonic lithotripsy system
Type: Class I

Manufacturer

Name: Gyrus ACMI, Inc.
Address: 9600 Louisiana Ave.
North Brooklyn Park, United States
Created Date: Jul 23, 2021

Authorized Representative

Name: KeyMed (Medical & Industrial Equipment) Ltd.
Relationship Type: UK Responsible Person
Address: Keymed House Stock Road
Southend-on-sea, Essex, United Kingdom
Postcode: SS2 5QH

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About this record

Pneumatic/ultrasonic lithotripsy system is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 119004. The device is manufactured by Gyrus ACMI, Inc. from United States, classified as General Medical Device. The authorized representative in the UK is KeyMed (Medical & Industrial Equipment) Ltd..

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