BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Planmed Oy

    Reg #: 8043728 · FEI: 3002807903 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Planmed Oy
    Registration Number
    8043728
    FEI Number
    3002807903
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Sorvaajankatu 7
    City
    Helsinki Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K213278

    Owner / Operator

    Firm Name
    Planmed Oy
    Operator Number
    10023610
    Address
    Asentajankatu 6
    City
    Helsinki
    State
    Uusimaa
    Postal Code
    00880
    Country
    FI
    Correspondent
    Niina M Vuorikallas

    US Agent

    Business Name
    Planmeca U.S.A. Inc.
    Contact Name
    Brett Hetherington
    Address
    11727 Fruehauf Dr
    City
    Charlotte
    State
    NC
    ZIP
    28273
    Country
    US
    Email
    [email protected]
    Phone
    612 8685872

    Products

    Device Name Product Code
    X-Ray, Tomography, Computed, Dental OAS
    System, X-Ray, Tomography, Computed JAK
    X-Ray, Computed Tomography, Cone-Beam SFV
    Full Field Digital, System, X-Ray, Mammographic MUE

    Proprietary Names

    Planmed Verity Planmed XFI Planmed Clarity 2D Planmed Clarity S

    Establishment Types

    Manufacture Medical Device