BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MAICO Diagnostics GmbH

    Reg #: 3002504821 · FEI: 3002504821 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    75
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    MAICO Diagnostics GmbH
    Registration Number
    3002504821
    FEI Number
    3002504821
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Sickingenstr. 70-71
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K083861

    Owner / Operator

    Firm Name
    DEMANT A/S
    Operator Number
    8010048
    Address
    KONGEBAKKEN 9, --
    City
    SMORUM
    State
    DK-NOTA
    Postal Code
    DK-2765
    Country
    DK

    Products

    Device Name Product Code
    Tester, Auditory Impedance ETY
    Audiometer EWO
    Stimulator, Auditory, Evoked Response GWJ
    Spirometer, Diagnostic BZG

    Proprietary Names

    Titan easyTymp Pro easyTymp touchTymp GSI AudioSol GSI 61 AD226 GSI AudioStar Pro Amplivox 240 Wizard Ultra RA660 Avant ARC AC40 AS608 MA28 Amplivox 116 Amplivox 170 AM282 MA39 Amplivox 270 PA5 Amplivox 260 AD229 MA25 AC33 MA41 MA40 AD629 Welch Allyn AM282 MA1 Avant Stealth Audiometer MA42 Amplivox 160 GSI 17 GSI Pello GSI AMTAS MA27 MA52 MA33 Avant A2D+ Audiometer Detective GSI 18 GSI AMTAS Flex SMART TONE Audiometer Luna AD528 CCA-200mini Audiometer RA360 modelONE CCA-100mini Audiometer Fit Test Audiometer NEXT Audiometer Amplivox Otosure easyTone Amplivox PC850 IP30 Insert earphone Amplivox 270+ B71 Bone conductor headset DD45 Headset TDH39 Headset B-81 Bone conductor headset DD65 Headset CIR Insert earphone DD450 High frequency headset Equinox Evo DD65v2 Audiometric headset Touch Keyboard GSI AudioHub Otoread EroScan Plus easyScreen MB 11 PILOT TEST MB 11 with BERAPhone Probe CCS-200 Spirometer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device