BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Spirotome

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

    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
    K190378

    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
    Forceps, Surgical, Gynecological HCZ
    Curette, Suction, Endometrial (And Accessories) HHK
    Instrument, Biopsy KNW

    Proprietary Names

    Spirotome

    Establishment Types

    Manufacture Medical Device