BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    TD Pilot

    Reg #: 3005301283 · FEI: 3005301283 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DYNAVOX Group AB
    Registration Number
    3005301283
    FEI Number
    3005301283
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lojtnantsgatan 25
    City
    Stockholm
    Country
    SE

    Owner / Operator

    Firm Name
    Tobii Dynavox LLC
    Operator Number
    9076359
    Address
    2100 Wharton Street, Suite 400
    City
    Pittsburgh
    State
    PA
    Postal Code
    15203
    Country
    US
    Correspondent
    Tony J Pavlik

    US Agent

    Business Name
    Tobii Dynavox LLC
    Contact Name
    Tony Pavlik
    Address
    2100 Wharton Street, Suite 400
    City
    Pittsburgh
    State
    PA
    ZIP
    15203
    Country
    US
    Email
    [email protected]
    Phone
    412 3814883 ext. 7957

    Products

    Device Name Product Code
    System, Communication, Powered ILQ

    Proprietary Names

    TD Pilot I-12+ I-16 I-15+ TD I-110 I-110 I-13 TD I-13 TD I-16

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility