United Kingdom MHRA device registration 74196

Fully-implantable middle ear implant system

United Kingdom flagUnited Kingdom·Active implantable device (Directive 90/385/EEC only)·Envoy Medical Corporation·Registered Apr 20, 2021
Registration details
Device ID
74196
Date Registered
Apr 20, 2021
Last Updated
Dec 22, 2022
Device classification
Device Type
Active implantable device (Directive 90/385/EEC only)
Devices
Fully-implantable middle ear implant system
Type
Active implantable Medical device
Manufacturer
Address
4875 White Bear Parkway
White Bear Lake , Minnesota, United States
Created Date
Apr 20, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
Concept House, 6 Stoneycroft Rise, Chandlers Ford, Eastleigh,
Hampshire, England, United Kingdom
Postcode: SO53 3LD
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Additional devices represented by ICON (LR) Limited in the UK

About this record

Fully-implantable middle ear implant system is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 74196. The device is manufactured by Envoy Medical Corporation from United States, classified as Active implantable device (Directive 90/385/EEC only). The authorized representative in the UK is ICON (LR) Limited.

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