BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AuDX - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06)

    Reg #: 3008111228 · FEI: 3008111228 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PATH
    Registration Number
    3008111228
    FEI Number
    3008111228
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Landsberger Strasse 65
    City
    Germering Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K133012

    Owner / Operator

    Firm Name
    PATH
    Operator Number
    10042983
    Address
    Landsberger Strasse 65
    City
    Germering
    State
    Bavaria
    Postal Code
    82110
    Country
    DE
    Correspondent
    Johann Oswald

    Products

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

    Proprietary Names

    AuDX - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06) AuDX PRO - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06) Sentiero - DD45/contra,HDA280,HDA300,B71,B81,PIEP/Mono(w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB04,AB05,AB06) AuDX PRO FLEX - DD45/contra,HDA280,HDA300,B71,B81,PIEP/Mono(w.FoamTips),,AB01,AB04,AB03,AB05,AB06) NavPRO ONE - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06) TY-101 - DD45/contra,DD65/DD65V2,HDA300,B81,PIEP/Mono(w.FoamTips),AB01,AB04,AB03,AB05,AB06)

    Establishment Types

    Manufacture Medical Device