BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KOFU FACTORY OF TERUMO CORP.

    Reg #: 9681835 · FEI: 3003752255 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    KOFU FACTORY OF TERUMO CORP.
    Registration Number
    9681835
    FEI Number
    3003752255
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1727-1 TSUIJIARAI, SHOWA-CHO
    City
    NAKAKOMA-GUN Yamanashi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    BK970008

    Owner / Operator

    Firm Name
    TERUMO CORP.
    Operator Number
    8010026
    Address
    44-1, 2-CHOME, HATAGAYA, --
    City
    SHIBUYA-KU, TOKYO
    State
    JP-NOTA
    Postal Code
    151-0072
    Country
    JP

    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
    Set, Transfer (Blood/Plasma) KSB
    Set, Administration, Intravascular FPA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    Terumo Sterile Tubing Welder (TSCD) TSCD Wafers Surflo Winged Infusion Set TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER Immucise Intradermal Injection System Surflash I.V. Catheter Surflash IV Catheter Venoject Luer Adaptor Venoject Luer Adapter

    Establishment Types

    Manufacture Medical Device