BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DIAGNOSTIC GROUP LLC

    Reg #: 2113281 · FEI: 2113281 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    105
    Establishment Types
    5
    Classifications
    7

    Registration Details

    Registration Name
    DIAGNOSTIC GROUP LLC
    Registration Number
    2113281
    FEI Number
    2113281
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10395 W 70th St
    City
    EDEN PRAIRIE
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011135

    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
    Audiometer EWO
    Stimulator, Auditory, Evoked Response GWJ
    Tester, Auditory Impedance ETY
    Tympanometer NAS
    Tympanometer, Exempt PTP
    Spirometer, Diagnostic BZG
    Electrode, Cutaneous GXY

    Proprietary Names

    Audera Ero-Scan Pro AT235 PILOT TEST Welch Allyn TM286 GSI 39 Race Car MI 22 Otowave 302+ Otowave 102-C Otowave 302 MB 11 GSI Corti Welch Allyn OAE GSI TympStar Otowave 202 GSI Allegro Welch Allyn MicroTymp 4 Sera GSI Novus MI 23 Titan easyTymp Pro easyTymp MI 26 MI 24 MI 20 MB 11 with BERAPhone Probe OtoWave 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 CCS-200 Spirometer MI 34 GSI TympStar Pro Middle Ear Analyzer (Model: GSI TympStar Pro) GSI 70 Otoread EroScan Plus Gold Tiptrodes Gold Eartip Electrode MI 44 MI 21 GSI AUDIOscreener + GSI AUDIOscreener

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)