BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ATMOS MEDIZINTECHNIK GMBH & CO. KG

    Reg #: 8010573 · FEI: 3003169291 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    ATMOS MEDIZINTECHNIK GMBH & CO. KG
    Registration Number
    8010573
    FEI Number
    3003169291
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LUDWIG-KEGEL-STRASSE 16
    City
    LENZKIRCH Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K232015

    Owner / Operator

    Firm Name
    ATMOS MEDIZINTECHNIK GMBH & CO. KG
    Operator Number
    8010573
    Address
    LUDWIG-KEGEL-STR. 16
    City
    LENZKIRCH
    State
    Baden-Wurttemberg
    Postal Code
    79853
    Country
    DE
    Correspondent
    Abdulaziz Abdunasimov

    US Agent

    Business Name
    ATMOS Inc.
    Contact Name
    Nathan Pohlit
    Address
    29 Dowlin Forge Road
    City
    Exton
    State
    PA
    ZIP
    19341
    Country
    US
    Email
    [email protected]
    Phone
    610 3517221

    Products

    Device Name Product Code
    Stimulator, Caloric-Air KHH
    Device, Medical Examination, Ac Powered KZF
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Laryngoscope, Nasopharyngoscope EQN
    Laryngostroboscope EQL
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Stimulator, Caloric-Water ETP
    Source, Carrier, Fiberoptic Light EQH
    Chair, Surgical, Ac-Powered GBB
    Unit, Examining/Treatment, Ent ETF
    Colposcope (And Colpomicroscope), Exempt PTZ
    Otoscope ERA
    Microscope, Surgical, General & Plastic Surgery FSO
    Camera, Television, Endoscopic, With Audio FWG

    Proprietary Names

    Varioair ATMOS EXAMINATION LIGHTS ATMOS Scope (507.7000); ATMOS Scope Pro (507.7050); ATMOS Scope iPrime (507.7060) ATMOS VideoScope PED ATMOS Video-Nasopharyngoscope, 3.9 mm ATMOS VideoScope ATMOS Nasopharyngoscope PED ATMOS Strobo 21 LED ATMOS STROBOSCOPES ATMOS C 361 ATMOS C 451 Hygrotherm plus Variotherm plus ATMOS LIGHT SOURCES ATMOS Scope ATMOS Scope Basic ATMOS C 051 ATMOS C 051 Thorax ATMOS SURGICAL CHAIRS ATMOS ENT EXAMINATION AND TREATMENT UNITS ATMOS i View 21 COLPO ATMOS i View 31 COLPO ATMOS OTOSCOPES ATMOS i View 31 ATMOS i View 21 ATMOS i View 31 PRO ATMOS i View 21 PRO ATMOS iQam ATMOS S 201 Thorax

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device