BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Bact-HME Port

    Reg #: 3005519819 · FEI: 3005519819 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHARMA SYSTEMS AB
    Registration Number
    3005519819
    FEI Number
    3005519819
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Datavagen 5
    City
    Lysekil Halland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K202459

    Owner / Operator

    Firm Name
    Pharma Systems AB
    Operator Number
    10036898
    Address
    Datavagen 5
    City
    lyekil
    State
    Halland
    Postal Code
    SE-453 38
    Country
    SE
    Correspondent
    David Rothkopf

    US Agent

    Business Name
    MEDIcept
    Contact Name
    David Rothkopf
    Address
    200 Homer Ave
    City
    Ashland
    State
    MA
    ZIP
    01721
    Country
    US
    Email
    [email protected]
    Phone
    617 8993449

    Products

    Device Name Product Code
    Filter, Bacterial, Breathing-Circuit CAH

    Proprietary Names

    Bact-HME Port Pharma Mini Port Bact-Trap Bact Trap Midi Bact-Trap Mini Bact-HME Pharma Mini Port Angle Pharma Mini Port Elbow Pharma Mini Bact-HME Midi

    Establishment Types

    Manufacture Medical Device