United Kingdom MHRA device registration 77787

Fully-implantable middle ear implant system vibrator assembly

United Kingdom·Active implantable device (Directive 90/385/EEC only)·Cochlear Boulder LLC ·Registered Apr 29, 2021

Registration details

Device ID: 77787
Date Registered: Apr 29, 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 vibrator assembly
Type: Active implantable Medical device

Manufacturer

Name: Cochlear Boulder LLC
Address: 5445 Airport Boulevard
Boulder, Colorado, United States
Created Date: Apr 29, 2021

Authorized Representative

Name: Cochlear Europe Ltd
Relationship Type: UK Responsible Person
Address: 6 Dashwood Lang Road Bourne Business Park
Addlestone, Surrey, England, United Kingdom
Postcode: KT15 2HJ

Similar products

Devices with a matching generic name or device type registered with MHRA

Soft-tissue/mesh anchor, non-bioabsorbableApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143460

Noninvasive device battery chargerApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143459

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connectionApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143463

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system external electrodeApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143457

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmerApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143458

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, extracorporealApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143462

Personal device holder, reusableApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143464

Neurosurgical procedure kit, non-medicated, single-useApr 5, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Stimwave Technologies Incorporated

Device ID: 143461

Ventricular prosthesis systemJan 31, 2022

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: SynCardia Systems, LLC

Device ID: 134519

Implantable sleep apnoea treatment system, fixed-rateNov 12, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Manufacturer: Nyxoah SA

Device ID: 112767

Other products from Cochlear Boulder LLC

Additional devices registered by the same manufacturer

Craniofacial fixation plate, non-bioabsorbableApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77782

Electrical-only medical device connection cable, reusableApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77784

Fully-implantable middle ear implant system sound processorApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77788

Hearing aid/implant system remote controlApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77785

Implant battery chargerApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77781

Audiometric/hearing device softwareApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77786

Hearing implant system external magnetApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77780

Partially-implantable middle ear implant system sound processorApr 29, 2021

Type: Active implantable device (Directive 90/385/EEC only)

Device ID: 77783

Other products from same authorized representative

Additional devices represented by Cochlear Europe Ltd in the UK

Bone-conduction hearing implant system sound processor/vibratorNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Bone Anchored Solutions AB

Device ID: 203033

External facial prosthesis attachment reference deviceNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Bone Anchored Solutions AB

Device ID: 203035

Hearing aid enhanced audio device, telecommunication/multimediaNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Bone Anchored Solutions AB

Device ID: 118889

Bone-conduction hearing implant system vibrator assemblyNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Ltd

Device ID: 153454

Cochlear electrode array introducer, reusableNov 26, 2024

Type: Active Implantable Device

Manufacturer: Cochlear Ltd

Device ID: 77905

Cochlear implant dummy magnetNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Ltd

Device ID: 186823

Cochlear implant implantable magnetNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Ltd

Device ID: 147116

Cochlear implant system waterproof kitNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Ltd

Device ID: 112103

Cochlear implant/auditory brainstem implant coilNov 26, 2024

Type: Active Implantable Device

Manufacturer: Cochlear Ltd

Device ID: 162006

Audiometric/hearing device softwareNov 26, 2024

Type: General Medical Device

Manufacturer: Cochlear Bone Anchored Solutions AB

Device ID: 203034

About this record

Fully-implantable middle ear implant system vibrator assembly is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 77787. The device is manufactured by Cochlear Boulder LLC from United States, classified as Active implantable device (Directive 90/385/EEC only). The authorized representative in the UK is Cochlear Europe Ltd.

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.

Free DatabasePowered by Pure Global AIMHRA RegisteredActive implantable device (Directive 90/385/EEC only)