BEUDAMED
    FDA Registration Active 🇨🇳 China

    TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.

    Reg #: 3004102031 · FEI: 3004102031 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    7

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    Registration Details

    Registration Name
    TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
    Registration Number
    3004102031
    FEI Number
    3004102031
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    M4-9-5,HANGZHOU ECONOMIC &, TECHNOLOGICAL DEVELOPMENT ZONE
    City
    HANGZHOU Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K031279

    Owner / Operator

    Firm Name
    Terumo Medical Products (Hangzhou) Co., LTD.
    Operator Number
    10033965
    Address
    M4-9-5, Hangzhou Economic &, Technological Development Zone
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310018
    Country
    CN

    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, Administration, Intravascular FPA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Midline Catheter PND
    Guide, Wire, Catheter, Neurovasculature MOF
    Wire, Guide, Catheter, Exempt PTL
    Device, Intravascular Catheter Securement KMK
    Clamp, Vascular DXC

    Proprietary Names

    Surshield® Safety Winged Blood Collection Set Surshield® Safety Winged Infusion Set SURFLO® Winged Infusion Set with Needle Protection SURFLO Midela Midline Catheter RADIFOCUS Torque Device SURFLO MIDELA™ Securement Device Surflo Winged Infusion Set SURFLO Hybria Closed System Safety IV Catheter TR Band

    Establishment Types

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