BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Rotaglide Lubricant

    Reg #: 3002631703 · FEI: 3002631703 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FRESENIUS KABI AB
    Registration Number
    3002631703
    FEI Number
    3002631703
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fresenius Kabi AB, Rapsgatan 7
    City
    Uppsala
    Country
    SE

    Regulatory Submissions

    PMA Number
    P900056

    Owner / Operator

    Firm Name
    Fresenius Kabi AB
    Operator Number
    10038639
    Address
    Fresenius Kabi AB, Rapsgatan 7
    City
    Uppsala
    State
    SE-C
    Postal Code
    75174
    Country
    SE
    Correspondent
    Carolina H Sjogren

    US Agent

    Business Name
    Sr. Director, Regulatory Affairs
    Contact Name
    Aparna Dagar
    Address
    Fresenius Kabi USA, LLC, Three Corporate Drive
    City
    Lake Zurich
    State
    IL
    ZIP
    60047
    Country
    US
    Email
    [email protected]
    Phone
    847 5502649

    Products

    Device Name Product Code
    Catheter, Coronary, Atherectomy MCX

    Proprietary Names

    Rotaglide Lubricant

    Establishment Types

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