BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Honeywell Healthcare Solutions GmbH (formerly EnviteC)

    Reg #: 9617268 · FEI: 1000352675 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Honeywell Healthcare Solutions GmbH (formerly EnviteC)
    Registration Number
    9617268
    FEI Number
    1000352675
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ALTER HOLZHAFEN 18
    City
    WISMAR Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K122290

    Owner / Operator

    Firm Name
    Honeywell Healthcare Solutions GmbH (formerly EnviteC)
    Operator Number
    10060527
    Address
    Alter Holzhafen 18
    City
    Wismar
    State
    Mecklenburg-Western Pomerania
    Postal Code
    23966
    Country
    DE
    Correspondent
    Stefan Miska

    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
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Devices, Breath Trapping, Alcohol DJZ
    Transducer, Gas Flow BXP

    Proprietary Names

    MySign O Oxygen Measuring Device AlcoQuant 6020 Plus Flow Sensor SpiroQuant H Flow Sensor SpiroQuant A+ Flow Sensor SpiroQuant EnviteC Medical Oxygen Sensors 6050-0004-110 MOX2 MOX9 MOX4 MOX6 MOX3

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility