BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    EpilMe

    Reg #: 3015779311 · FEI: 3015779311 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BERGER & KRAFT
    Registration Number
    3015779311
    FEI Number
    3015779311
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Slowikowski 85 Street,
    City
    RASZYN Mazowieckie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K213261

    Owner / Operator

    Firm Name
    Berger & Kraft
    Operator Number
    10061213
    Address
    Slowikowski 85 Street
    City
    RASZYN
    State
    PL-NOTA
    Postal Code
    05-090
    Country
    PL
    Correspondent
    Zaneta Trzaskowska

    US Agent

    Business Name
    Neauvia North America
    Contact Name
    Joy Willard
    Address
    8480 HONEYCUTT RD
    City
    Raleigh
    State
    NC
    ZIP
    27615
    Country
    US
    Email
    [email protected]
    Phone
    984 7775296

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    EpilMe ALIYA

    Establishment Types

    Manufacture Medical Device