BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    M-09M

    Reg #: 9613449 · FEI: 3002739067 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    70
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IT DR. GAMBERT GMBH
    Registration Number
    9613449
    FEI Number
    3002739067
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HINTER DEM CHOR 21
    City
    WISMAR Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K002384

    Owner / Operator

    Firm Name
    IT DR. GAMBERT GMBH
    Operator Number
    9042424
    Address
    HINTER DEM CHOR 21, --
    City
    WISMAR, M-V
    State
    Mecklenburg-Western Pomerania
    Postal Code
    23966
    Country
    DE
    Correspondent
    Demian - Gambert

    US Agent

    Business Name
    INTERNATIONAL BUSINESS STRATEGIES
    Contact Name
    WILLIAM ROETTGER
    Address
    2061 Middle Street, #35
    City
    Sullivans Is
    State
    SC
    ZIP
    29482
    Country
    US
    Email
    [email protected]
    Phone
    843 2240553 ext. 0

    Products

    Device Name Product Code
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL

    Proprietary Names

    M-09M M-01TL2 M-43T M-16T M-07ST M-09T M-03T M-43 M-14ST M-47 M-02TL2 M-25 MLF-16 M-15T M-14T M-01 to M-18 M-44 M-25T M-47T M-12T M-18CT M-07T M-01 to M-18 incl. Flow Diverter M-25 incl. Flow Diverter M-48T MLF-60 M-02L2 M-04T M-08T M-01L2 MLF-60HC M-48 MLF-19 M-16HT M-80 MLF-15 MLF-19GE M-04C M-47 incl. Flow Diverter MLF-03 MLF-650 MLF-16H M-43GE MLF-43GE MLF-350 M-15M M-03T incl. Flow Diverter M-16HTT MLF-04 M-44PI MLF-10B M-12A M-45 M-01T to M-18T M-16PT M-12 incl. translucent Flow Diverter M-07S M-16VT Sensors O2 2PK M-43GE MLF-16D M-15TD M-12 incl. white Flow Diverter MLF-43GE D.p. M-18T M-43T/ D.p. M-43 D.p. MLF-16DE MLF-12A M-19GE M-48 incl. Flow Diverter

    Establishment Types

    Manufacture Medical Device