BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    IMUGARD WB PLT Platelet Pooling Set

    Reg #: 3011720361 · FEI: 3011720361 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Terumo BCT Vietnam Co., Ltd.
    Registration Number
    3011720361
    FEI Number
    3011720361
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Long Duc Industrial Park, Long Duc Commune
    City
    Long Thanh District Dong Nai
    Country
    VN

    Regulatory Submissions

    510(k) Number
    BK210658

    Owner / Operator

    Firm Name
    Terumo BCT, INC.
    Operator Number
    9002708
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80215
    Country
    US
    Correspondent
    Corrine Lucas

    US Agent

    Business Name
    Terumo BCT, Inc.
    Contact Name
    Corrine Lucas
    Address
    10811 W Collins Ave
    City
    Lakewood
    State
    CO
    ZIP
    80215
    Country
    US
    Email
    [email protected]
    Phone
    720 6106034

    Products

    Device Name Product Code
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR

    Proprietary Names

    IMUGARD WB PLT Platelet Pooling Set

    Establishment Types

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