BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Phonak Virto P

    Reg #: 3008848788 · FEI: 3008848788 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    84
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Sonova USA Inc.
    Registration Number
    3008848788
    FEI Number
    3008848788
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    444 Commerce Street
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US

    Owner / Operator

    Firm Name
    Sonova AG
    Operator Number
    9028479
    Address
    Laubisruetistrasse 28
    City
    Staefa
    State
    Zurich
    Postal Code
    8712
    Country
    CH

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM

    Proprietary Names

    Phonak Virto P Moxi B DX Stride P R Au A Phonak Bolero M Phonak Slim L-R Unitron Remote Plus Phonak Sky Link M Insera B Phonak Terra+ RIC-R T Stride Unitron TrueFit Phonak Slim P-R Vista V Aura:fit Relate Phonak CROS L Phonak Brio 5 I Au B Naida CI Connect Vista B DX Stride M Phonak Audeo M AudioNova B Phonak Audeo I ampli-energy B Trial L Stride B AudioNova S Phonak Sky L Star Evolution ampli-energy R Trial 5P ampli-mini R L PH Phonak Audeo L Phonak Naida Link CROS Phonak Audeo I-Sphere T Insera Phonak CROS P Vista DX Phonak Audeo P T Max MEMINI E 5P R-R PH T Moxi Phonak Sky M Au 3 Sennheiser Sonite R Au V Phonak Virto M HelloGO Phonak Audeo P-RL Moxi S Phonak Naida M Phonak Naida P ampli-connect R Trial L ampli-connect R L PH Aura:fit AudioNova T Phonak Target Phonak Brio 5 Move AudioNova V Vista S Phonak CROS I Phonak Naida L ampli-energy B L RP PH Relate3 Sonite R Kit Stride V RELATE 2 Phonak Naida Link Vista T Au Basic+ ampli-energy R 5P R PH Hearing Remote Phonak Naida Link M Easy Line Remote Relate4 HANSATON stream remote DX Insera myPhonak Relate3.1 Relate 5 Phonak Audeo L-R Fit Aura:fit AudioNova Phonak Audeo P-R Fit Moxi V AudioNova DX

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device