United Kingdom MHRA device registration 77786
Audiometric/hearing device software
United Kingdom·Active implantable device (Directive 90/385/EEC only)·Cochlear Boulder LLC ·Registered Apr 29, 2021Registration details
- Device ID
- 77786
- Date Registered
- Apr 29, 2021
- Last Updated
- Dec 22, 2022
Device classification
- Device Type
- Active implantable device (Directive 90/385/EEC only)
- Devices
- Audiometric/hearing device software
- Type
- Active implantable Medical device
Manufacturer
- Address
- 5445 Airport Boulevard Boulder, Colorado, United States
- Created Date
- Apr 29, 2021
Authorized Representative
- Relationship Type
- UK Responsible Person
- Address
- 6 Dashwood Lang Road Bourne Business Park Addlestone, Surrey, England, United KingdomPostcode: KT15 2HJ
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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
Fully-implantable middle ear implant system vibrator assemblyApr 29, 2021
Type: Active implantable device (Directive 90/385/EEC only)
Device ID: 77787
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
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Device ID: 170747
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About this record
Audiometric/hearing device software is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 77786. 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.
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