BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Bindex BI-2 Kit v4 (w/o Gel)

    Reg #: 3013328880 · FEI: 3013328880 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BONE INDEX FINLAND LTD.
    Registration Number
    3013328880
    FEI Number
    3013328880
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Savilahdentie 14
    City
    Kuopio Pohjois-Savo
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K211350

    Owner / Operator

    Firm Name
    Bone Index Finland Ltd.
    Operator Number
    10052487
    Address
    Savilahdentie 14
    City
    Kuopio
    State
    Pohjois-Savo
    Postal Code
    70700
    Country
    FI
    Correspondent
    Janne P Karjalainen

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Bone Sonometer MUA

    Proprietary Names

    Bindex BI-2 Kit v4 (w/o Gel) Bindex BI-2 Kit v1 (w/ Gel) Bindex BI-2 Bindex BI-2 Kit v2 (w/o Gel) Bindex BI-2 Kit v3 (w/o Gel) Bindex Measure BI-41

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device