BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    AGXO B (SBO Hearing)

    Reg #: 3017441596 · FEI: 3017441596 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    87
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Demant Operations, S.a. De C.v.
    Registration Number
    3017441596
    FEI Number
    3017441596
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Boulevard Corredor Tijuana-Rosarito 2000, #24702 H-1, Ejido Francisco Villa
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K133308

    Owner / Operator

    Firm Name
    DEMANT A/S
    Operator Number
    8010048
    Address
    KONGEBAKKEN 9, --
    City
    SMORUM
    State
    DK-NOTA
    Postal Code
    DK-2765
    Country
    DK
    Correspondent
    Veronique Schou

    US Agent

    Business Name
    Oticon Inc.
    Contact Name
    Love Aggarwal
    Address
    580 Howard Ave
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    732 8534740

    Products

    Device Name Product Code
    Masker, Tinnitus KLW

    Proprietary Names

    AGXO B (SBO Hearing) Oticon Jet PX (SBO Hearing) AGXO F (SBO HEARING) Oticon Own SI (SBO Hearing) Alta2 Pro TI (Oticon) Opn 3 (Oticon) Opn S (Oticon) Viron 9 (Bernafon) Nera2 Pro TI (Oticon) Coral (Bernafon) Ria2 (Oticon) Opn 2 (Oticon) Ria2 Pro Tl (Oticon) Viron 5 (Bernafon) SoundLink2 App (Sonic) Viron 7 (Bernafon) Alta2 Pro (Oticon) Nera2 Pro (Oticon) EasyControl-A (Bernafon) Zerena 5 (Bernafon) Capto (Bernafon) Captivate™ (Sonic) Opn 1 (Oticon) Enchant ™ family (Sonic) Opn Play (Oticon) Zerena 1 (Bernafon) Oticon More (SBO Heraing) Ria (Oticon) Zerena 9 (Bernafon) Sonic Expressfit Pro (Sonic) Bernafon Alpha (SBO Hearing) Alta2 (Oticon) Nera2 (Oticon) Ria2 Pro (Oticon) Siya (Oticon) Zerena 3 (Bernafon) Oticon ON App (Oticon) Viron 1 (Bernafon) Ria Pro (Oticon) Ruby (Oticon) Viron 3 (Bernafon) Zerena 7 (Bernafon) Oticon Genie2 (Oticon) Sonic Radiant (SBO Hearing) Bernafon OasisNxt (Bernafon) Oticon Zircon (SBO Hearing) Sonic ExpressfitPro (SBO Hearing) Oticon Companion (SBO Hearing) Oticon Real (SBO Hearing) CAPTO 5 (Bernafon) RemoteLink 2 (SBO Hearing) EarQ F (SBO Hearing) Bernafon Alpha XT (SBO Hearing) AGXO E (SBO Hearing) Oticon Own (SBO Hearing) Philips HearLink 40 (SBO Hearing) Oticon Intent (SBO Hearing) Oticon Charger miniRITE (SBO Hearing) Oticon SmartCharger miniRITE (SBO Hearing) SmartCharger miniRITE (SBO Hearing) Charger Plus MNR (SBO Hearing) AudigyFit 2 (SBO Hearing) Bernafon App (SBO Hearing) CAPTO 3 (Bernafon) SoundLink 3 (SBO Hearing) Sonic Radiant SE (SBO Hearing) Philips HearLink 2 (SBO Hearing) HHM G S (Oticon) Charger miniRITE (SBO Hearing) Bernafon Charger Plus MNR (SBO Hearing) Bernafon Entra B (SBO Hearing) Neutral RC-A (SBO Hearing) Neutral Charger Plus MNB T R (SBO Hearing) Philips HearSuite (SBO Hearing) AGXO G S (Oticon) AGXO F (SBO Hearing) EarQ G S (Oticon) AGXO Hearing B (SBO Hearing) Bernafon Encanta (SBO Hearing) Bernafon Charger MNR (SBO Hearing) Neutral TV-A (SBO Hearing) Oticon Genie 2 (SBO Hearing) Charger MNR (SBO Hearing) Birdsong AOXT (SBO Hearing) Philips HearLink 50 (SBO Hearing) Neutral Oasisnxt Custom (SBO Hearing) Neutral Charger Plus MNR T R (SBO Hearing)

    Establishment Types

    Repack or Relabel Medical Device