Fully-implantable middle ear implant system - UK MHRA Medical Device Registration
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.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Device Type
Active implantable device (Directive 90/385/EEC only)
Devices
Fully-implantable middle ear implant system
Type
Active implantable Medical device
Date Registered
Apr 20, 2021
Last Updated
Dec 22, 2022
Address
4875 White Bear Parkway
White Bear Lake , Minnesota, United States
Created Date
Apr 20, 2021
Relationship Type
Address
Concept House, 6 Stoneycroft Rise, Chandlers Ford, Eastleigh,
Hampshire, England, United Kingdom
Postcode: SO53 3LD
Soft-tissue/mesh anchor, non-bioabsorbable
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Noninvasive device battery charger
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connection
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system external electrode
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, extracorporeal
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Personal device holder, reusable
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Neurosurgical procedure kit, non-medicated, single-use
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Stimwave Technologies Incorporated
Ventricular prosthesis system
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: SynCardia Systems, LLC
Implantable sleep apnoea treatment system, fixed-rate
Type: Active implantable device (Directive 90/385/EEC only)
Manufacturer: Nyxoah SA
Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Type: General Medical Device
Manufacturer: Si-Bone, Inc.
Fluted surgical drill bit, reusable
Type: General Medical Device
Manufacturer: Si-Bone, Inc.
Electrocardiographic lead set, reusable
Type: General Medical Device
Manufacturer: SigmaStim Domestic, LLC
Electroconvulsive therapy system
Type: General Medical Device
Manufacturer: SigmaStim Domestic, LLC
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Type: General Medical Device
Manufacturer: Si-Bone, Inc.
Thrombectomy suction catheter
Type: General Medical Device
Manufacturer: MIVI Neuroscience, Inc
Electrical mains power cable
Type: General Medical Device
Manufacturer: Venclose, Inc
Percutaneous radio-frequency ablation system generator
Type: General Medical Device
Manufacturer: Venclose, Inc
Suction/irrigation tubing, single-use
Type: General Medical Device
Manufacturer: MIVI Neuroscience, Inc
Vascular guide-catheter, single-use
Type: General Medical Device
Manufacturer: MIVI Neuroscience, Inc

