BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Planmeca ProMax with DEC

    Reg #: 8030876 · FEI: 1000207287 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Planmeca Oy
    Registration Number
    8030876
    FEI Number
    1000207287
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Asentajankatu 6
    City
    Helsinki Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K051464

    Owner / Operator

    Firm Name
    Planmeca Oy
    Operator Number
    10023612
    Address
    Asentajankatu 6
    City
    Helsinki
    State
    Uusimaa
    Postal Code
    00880
    Country
    FI
    Correspondent
    Niina M Vuorikallas

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH
    Unit, X-Ray, Extraoral With Timer EHD

    Proprietary Names

    Planmeca ProMax with DEC

    Establishment Types

    Manufacture Medical Device