BEUDAMED
    FDA Registration Active 🇬🇷 Greece

    CHOLESTEROL

    Reg #: 3006716639 · FEI: 3006716639 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    MEDICON HELLAS SA
    Registration Number
    3006716639
    FEI Number
    3006716639
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MELITONA 5-7
    City
    GERAKAS Attiki
    Country
    GR

    Regulatory Submissions

    510(k) Number
    K232404

    Owner / Operator

    Firm Name
    MEDICON HELLAS SA
    Operator Number
    10036719
    Address
    MELITONA 5-7
    City
    GERAKAS
    State
    Attiki
    Postal Code
    15344
    Country
    GR
    Correspondent
    SOTIRIA MITROPOULOU

    US Agent

    Business Name
    Diatron US Inc.
    Contact Name
    Frank Matuszak
    Address
    12601 NW 115th Avenue Suite A 113
    City
    Medley
    State
    FL
    ZIP
    33178
    Country
    US
    Email
    [email protected]
    Phone
    833 2287931

    Products

    Device Name Product Code
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    System, Test, Low Density, Lipoprotein MRR
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS

    Proprietary Names

    CHOLESTEROL LDL-Cholesterol HDL-Cholesterol TRIGLYCERIDES

    Establishment Types

    Manufacture Medical Device