BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set

    Reg #: 3011720361 · FEI: 3011720361 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    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
    BK150321

    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
    Separator, Automated, Blood Cell, Diagnostic GKT

    Proprietary Names

    Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set Trima Accel LRS Platelet, Plasma, RBC Set Trima Accel LRS Platelet, Plasma Set Trima Accel LRS Platelet, Plasma, RBC + Auto PAS Set Trima Accel Auto RBC, Plasma Set Trima Accel RBC, Plasma Set Trima Accel Platelet + Sampler, Plasma, Auto RBC Set Traim Accel MultiPlasma Set Trima Accel LRS Platelet + Sampler, Plasma, RBC Set Trima Accel Platelet + Sampler, MultiPlasma RBC Set Trima Accel Platelet, Plasma, Auto RBC Set Platelet Additive Solution Connection Adapter Trima Accel LRS Platelet, Plasma, Auto RBC Set Trima Accel LRS Platelet + 35 mL Sampler, Plasma, Auto RBC Set Anticoagulant Connection Adapter Trima Accel LRS Platelet + 35 mL Sampler Multiplasma RBC Set Trima Accel Platelet Plasma RBC Set Trima Platelet Sampler Plasma RBC Set Trima Platelet + Sampler Plasma RBC Set

    Establishment Types

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