BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    TERUMO EUROPE N.V.

    Reg #: 9681413 · FEI: 3001570557 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    TERUMO EUROPE N.V.
    Registration Number
    9681413
    FEI Number
    3001570557
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    INTERLEUVENLAAN 40
    City
    LEUVEN Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K023271

    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, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Set, Administration, Intravascular FPA
    Syringe, Antistick MEG
    Ophthalmic Needle QYM

    Proprietary Names

    Terumo Syringe K-Pack II Needle 27Gx3/4 Thin Wall K-Pack Embrace Active Safety Needle K-Pack II K-Pack Surshield Needle, Hypodermic Needle for Single Use SURFLO® Winged Infusion Set With Filter and Needle Protection (Surshield®) K-Pack II Needle - 21G x 2 K-Pack II Needle - 30G x 1/2" Ultra Thin Wall K-Pack II Needles 27G x 1/2” Extra Thin Wall K-Pack II Needle - 30G x 1/2" Extra Thin Wall K-Pack II Needle - 27G x 1/2" Ultra Thin Wall K-Pack II 29G SurGuard®3 Safety Hypodermic Needle K-Pack II Needle 27G & 30G Thin Wall Terumo SurGuard®3 Safety Hypodermic Needle Terumo SurGuard®3 Safety Hypodermic Needle & Terumo SurGuard®3 Hypodermic Syringe with Safety Needle K-Pack II Needle - 29Gx5/16" Thin Wall K-Pack II Needle - 29G Thin Wall Surflo Winged Infusion Set With Needle Protection (Surshield) Terumo Surguard2 Safety Needle 27G X 1/2 Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/mL FSH K-Pack Enhance Needle 27G x 1/2" TW K-Pack Surshield Needle with Safety Needle, Surguard 3 Safety Needle, Surguard 3 Safety Syringe Terumo SurGuard3 Safety Needle and Terumo SurGuard3 Hypodermic Syringe Terumo Injection Filter Needle

    Establishment Types

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