BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Unite Connect for Clinical Systems

    Reg #: 3008855170 · FEI: 3008855170 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASCOM US, INC.
    Registration Number
    3008855170
    FEI Number
    3008855170
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    300 Perimeter Park Dr Ste D
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180566

    Owner / Operator

    Firm Name
    ASCOM SWEDEN AB
    Operator Number
    10037837
    Address
    300 Perimeter Park Drive
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US

    Products

    Device Name Product Code
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    Unite Connect for Clinical Systems

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198