BEUDAMED
    FDA Registration Active 🇬🇷 Greece

    MEDICON HELLAS SA

    Reg #: 3006716639 · FEI: 3006716639 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    21

    Registration Details

    Registration Name
    MEDICON HELLAS SA
    Registration Number
    3006716639
    FEI Number
    3006716639
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MELITONA 5-7
    City
    GERAKAS Attiki
    Country
    GR

    Regulatory Submissions

    510(k) Number
    K200898

    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
    Photometric Method, Iron (Non-Heme) JIY
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Colorimetric Method, Gamma-Glutamyl Transpeptidase JPZ
    Acid, Uric, Uricase (Colorimetric) KNK
    Biuret (Colorimetric), Total Protein CEK
    Diazo Colorimetry, Bilirubin CIG
    Azo Dye, Calcium CJY
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Hexokinase, Glucose CFR
    Bromcresol Green Dye-Binding, Albumin CIX
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Antisera, All Groups, Streptococcus Spp. GTZ
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    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

    Iron ALT/SPGT LDH GGT Uric Acid Total Protein Medicon Hellas Creatinine Medicon Hellas Total Bilirubin Medicon Hellas Glucose Medicon Hellas Direct Bilirubin Medicon Hellas Calcium Medicon Hellas Albumin Medicon Hellas Urea Nitrogen UIBC AST/SGOT MEDICON HELLAS SA ASO Phosphorus CHOLESTEROL HDL-Cholesterol LDL-Cholesterol TRIGLYCERIDES

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)