BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Terumo SurGuard3 Safety Needle and Terumo SurGuard3 Hypodermic Syringe

    Reg #: 9681413 · FEI: 3001570557 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TERUMO EUROPE N.V.
    Registration Number
    9681413
    FEI Number
    3001570557
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    INTERLEUVENLAAN 40
    City
    LEUVEN Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K113422

    Owner / Operator

    Firm Name
    Terumo Europe N.V.
    Operator Number
    10034088
    Address
    Interleuvenlaan 40
    City
    Leuven
    State
    Vlaams Brabant
    Postal Code
    3001
    Country
    BE

    US Agent

    Business Name
    Terumo Medical Corp
    Contact Name
    Dina Justice
    Address
    950 Elkton Blvd
    City
    Elkton
    State
    MD
    ZIP
    21921
    Country
    US
    Email
    [email protected]
    Phone
    410 3927226

    Products

    Device Name Product Code
    Syringe, Antistick MEG
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Terumo SurGuard3 Safety Needle and Terumo SurGuard3 Hypodermic Syringe with Safety Needle, Surguard 3 Safety Needle, Surguard 3 Safety Syringe

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device