BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CORTEX BIOPHYSIK GMBH

    Reg #: 9680276 · FEI: 3010320336 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CORTEX BIOPHYSIK GMBH
    Registration Number
    9680276
    FEI Number
    3010320336
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Walter-Koehn-Str. 2d
    City
    LEIPZIG Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K993641

    Owner / Operator

    Firm Name
    CORTEX BIOPHYSIK GMBH
    Operator Number
    9007843
    Address
    WALTER-KOEHN-STR. 2d, --
    City
    LEIPZIG
    State
    Saxony
    Postal Code
    04356
    Country
    DE
    Correspondent
    Daniel - Postler

    US Agent

    Business Name
    AJW Technology Consultants, Inc.
    Contact Name
    Jon Ward
    Address
    11705 Boyette Road, #503
    City
    Riverview
    State
    FL
    ZIP
    33569
    Country
    US
    Email
    [email protected]
    Phone
    813 6452855 ext. 104

    Products

    Device Name Product Code
    Calculator, Predicted Values, Pulmonary Function BTY
    Calculator, Pulmonary Function Data BZC

    Proprietary Names

    MetaSoft MetaLyzer 3B MetaSoft Studio MetaLyzer MetaMax 3B MetaMax

    Establishment Types

    Manufacture Medical Device