BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Multicompatible EnviteC Reusable and Disposable SpO2 Sensors

    Reg #: 9617268 · FEI: 1000352675 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Honeywell Healthcare Solutions GmbH (formerly EnviteC)
    Registration Number
    9617268
    FEI Number
    1000352675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ALTER HOLZHAFEN 18
    City
    WISMAR Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K992215

    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
    Oximeter DQA

    Proprietary Names

    Multicompatible EnviteC Reusable and Disposable SpO2 Sensors

    Establishment Types

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