BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Coramate

    Reg #: 3007513241 · FEI: 3007513241 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BIONCISE NV
    Registration Number
    3007513241
    FEI Number
    3007513241
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bodemstraat 16/3
    City
    Wellen Limburg
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K060384

    Owner / Operator

    Firm Name
    Bioncise NV
    Operator Number
    10028101
    Address
    Bodemstraat 16
    City
    Wellen
    State
    Limburg
    Postal Code
    B-3830
    Country
    BE
    Correspondent
    Jaak Janssens

    US Agent

    Business Name
    Cook Myosite
    Contact Name
    Ryan Pruchnic
    Address
    100 Delta Dr,
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US
    Email
    [email protected]
    Phone
    412 9637380

    Products

    Device Name Product Code
    Instrument, Biopsy KNW

    Proprietary Names

    Coramate Spirotome

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device