BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Bd EleVation Breast Biopsy System

    Reg #: 3007162296 · FEI: 3007162296 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ferrosan Medical Devices Sp. z o.o.
    Registration Number
    3007162296
    FEI Number
    3007162296
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Koksowa 3
    City
    Szczecin Zachodniopomorskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K211933

    Owner / Operator

    Firm Name
    Ferrosan Medical Devices Sp. z o.o.
    Operator Number
    10029691
    Address
    Koksowa 3
    City
    Szczecin
    State
    Zachodniopomorskie
    Postal Code
    70-031
    Country
    PL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Instrument, Biopsy KNW

    Proprietary Names

    Bd EleVation Breast Biopsy System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)