BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Oticon Medical AB

    Reg #: 3007367732 · FEI: 3007367732 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    148
    Establishment Types
    4
    Classifications
    6

    Registration Details

    Registration Name
    Oticon Medical AB
    Registration Number
    3007367732
    FEI Number
    3007367732
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Datavagen 37B
    City
    Askim Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K103594

    Owner / Operator

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

    US Agent

    Business Name
    OTICON MEDICAL, LLC
    Contact Name
    Laura Dixon
    Address
    580 Howard Ave, Somerset
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    760 9082393 ext. 181

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB
    Hearing Aid, Bone Conduction, Implanted MAH
    Hearing Aid, Air-Conduction, Prescription ESD
    Active Implantable Bone Conduction Hearing System PFO
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Instrument, Ent Manual Surgical LRC

    Proprietary Names

    Ponto bone anchored hearing system Ponto Bone Anchored Hearing System Wide countersink, 3 mm Wide countersink, 4 mm Wide implant, 3 mm Wide implant, 4 mm Soft band, Black Head band Healing cap Square fit connection, machine Handle with screwdriver Abutment inserter, machine Soft band, Navy blue Soft band, Light blue Soft band, Pink Counter torque wrench Soft band, bilateral, Black Screwdriver hexagon Soft band, bilateral, Pink Sound processor indicator Soft band, bilateral, Navy blue Screwdriver, machine Guide drill, 3 - 4 mm Soft band, bilateral, Beige Soft band, bilateral, Red Soft band, Red Soft band, Beige Soft band, bilateral, Light blue Test band Cover screw hexagon MONO Surgery Kit Wide implant, 4 mm, with Abutment, 14 mm Abutment, 14 mm Ruler Genie Medical BAHS 2023.1 Genie Medical BAHS 2022.1 Ponto 5 SuperPower Softband 5 Genie Medical BAHS 2024.2 Instant SoundConnector Ponto 3 Power, R, STG Ponto Soft band, grey Ponto Soft band, bilateral, grey Ponto SoundConnector Ponto 3, R, PUW Ponto 3 Power, R, PUW Ponto 3 SuperPower Demo, R, CBE Genie Medical Ponto 3 SuperPower, L, STG Ponto Soft band, bilateral, blue Ponto 3 SuperPower, R, WHS Ponto Soft band, bilateral, indigo Ponto 3 SuperPower, R, CBE Ponto Soft band, bilateral, purple Ponto 3 Power, L, DBL Ponto 3 SuperPower, L, MBR Ponto Soft band, red Ponto Soft band, bilateral, red Ponto 3 SuperPower, L, CBE Ponto Soft band, cerise Ponto Soft band, bilateral, cerise Ponto 3, R, DBL Ponto 3 Power, R, DBL Ponto 3, R, MBR Ponto 3 Power, R, MBR Ponto Soft band, purple Demo BL Oticon Medical Streamer Ponto 3 Demo, R, CBE Ponto 3 SuperPower, R, DBL Ponto Soft band, yellow Ponto Soft band, bilateral, yellow Ponto 3 Power, R, CBE Ponto Soft band, indigo Ponto 3 SuperPower, L, WHS Ponto Soft band, bilateral, navy Ponto Soft band, black Ponto Soft band, bilateral, black Ponto 3 Power, L, PUW Ponto Soft band, brown Ponto Soft band, bilateral, brown Ponto 3, L, CBE Ponto 3 Power, L, CBE Ponto Soft band, navy Ponto 3 Power, L, STG Ponto Soft band, green Ponto 3 Power, R, WHS Ponto Soft band, turquoise Ponto 3 SuperPower, R, MBR Ponto Soft band, pink Ponto Soft band, bilateral, pink Ponto Soft band, bilateral, beige Ponto 3 Demo, L, CBE Ponto 3 SuperPower, L, DBL Ponto Soft band, beige Ponto 3, R, CBE Ponto 3 Power, L, WHS Ponto Soft band, blue Ponto 3, L, STG Ponto 3 SuperPower, L, PUW Ponto 3, L, MBR Ponto 3 Power, L, MBR BL Oticon Medical Streamer Ponto Soft band, bilateral, green Ponto 3, L, DBL Ponto 3, L, WHS Ponto 3, R, WHS Ponto 3 SuperPower, R, STG Ponto 3, R, STG Ponto 3 SuperPower, R, PUW Ponto 3, L, PUW Ponto 3 SuperPower Demo, L, CBE WH Oticon Medical Streamer Ponto Soft band, bilateral, turquoise Ponto 4 Genie Medical BAHS Sentio 1 Mini, DBL Spare Fixation Screws Sentio Ti Implant Kit Sentio 1 Mini, CBE Sentio 1 Mini, SIL Sentio 1 Mini, STG Sentio 1 Mini, TC Sentio 1 Mini, CNB Sentio Position Marker, non-sterile Screwdriver HexaDrive Sterilization cassette Ponto 5 Mini Ponto BHX Implant, 4 mm, with abutment, 9 mm Ponto BHX Implant, 4 mm, with abutment, 14 mm Ponto BHX Implant, 4 mm Ponto BHX Implant, 3 mm, with abutment, 9 mm Ponto BHX Implant, 3 mm, with abutment, 6 mm Ponto BHX Implant, 4 mm, with abutment, 6 mm MIPS Surgery kit, 4 mm Double-ended dissector Ponto BHX Implant, 3 mm MIPS Back-up kit, 3 mm Soft healing cap Ponto BHX Implant, 4 mm, with abutment, 12 mm Wide implant, 4 mm, with Abutment, 9 mm Wide implant, 3 mm, with Abutment, 9 mm Wide implant, 4 mm, with Abutment, 6mm Wide implant, 3 mm, with Abutment, 6 mm Abutment, 6 mm Abutment, 12mm Wide implant, 4 mm, with Abutment, 12 mm Abutment, 9 mm Torque Wrench

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Foreign Private Label Distributor