BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    BLUEPOINT MEDICAL GMBH & CO. KG

    Reg #: 3012834717 · FEI: 3012834717 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    BLUEPOINT MEDICAL GMBH & CO. KG
    Registration Number
    3012834717
    FEI Number
    3012834717
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    An der Trave 15
    City
    Selmsdorf Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K162014

    Owner / Operator

    Firm Name
    Bluepoint Medical GmbH & Co. KG
    Operator Number
    10054095
    Address
    An der Trave 15
    City
    Selmsdorf
    State
    Mecklenburg-Western Pomerania
    Postal Code
    23923
    Country
    DE
    Correspondent
    Stephen H Gorski

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

    Device Name Product Code
    Oximeter DQA
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL

    Proprietary Names

    NELLCOR FLEXMAX-P-HC Flexible SpO2 Sensor, Reusable, Homecare, Small NELLCOR FLEXMAX-P Flexible SpO2 Sensor, Reusable, Small NELLCOR FLEXMAX Flexible SpO2 Sensor, Reusable NELLCOR FLEXMAX-HC Flexible SpO2 Sensor, Reusable, Homecare 5514182 Gas exhaust line, 1 m/3.3 ft 5514183 Gas exhaust line, 0.18 m/7 in 5514184 Gas exhaust line, 2 m/6.6 ft Airway Gas Sampling Products

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device