BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    L1P-1F

    Reg #: 3015172511 · FEI: 3015172511 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3Shape Poland Sp. zo.o
    Registration Number
    3015172511
    FEI Number
    3015172511
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Poludniowa 27c
    City
    Szczecin Zachodniopomorskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K221249

    Owner / Operator

    Firm Name
    3Shape A/S
    Operator Number
    10023901
    Address
    Holmens Kanal 7
    City
    Copenhagen K
    State
    Hovedstaden
    Postal Code
    1060
    Country
    DK
    Correspondent
    David Rothkopf

    Products

    Device Name Product Code
    Laser, Fluorescence Caries Detection NBL

    Proprietary Names

    L1P-1F

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)