BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    Activation Element

    Reg #: 3008215723 · FEI: 3008215723 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    L Z FORM KFT
    Registration Number
    3008215723
    FEI Number
    3008215723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ipari Park Nyugat hrsz. 5704/4
    City
    Ajka Veszprem
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K090986

    Owner / Operator

    Firm Name
    L Z Form Kft
    Operator Number
    10043808
    Address
    Ipari Park Nyugat hrsz. 5704/4
    City
    Ajka
    State
    Veszprem
    Postal Code
    8400
    Country
    HU
    Correspondent
    Jozsef Polyik

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN
    Dispenser, Cement KIH

    Proprietary Names

    Activation Element First Fracture Kit PowerCurve Blister Tray Assembly for StabiliT MX with PowerCURVE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)