BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Plasmaflo OP-05W(A)

    Reg #: 8010002 · FEI: 3002806407 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Asahi Kasei Medical MT Corp. Oita Works
    Registration Number
    8010002
    FEI Number
    3002806407
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2111-2 OAZA SATO
    City
    OITA-SHI
    Country
    JP

    Regulatory Submissions

    PMA Number
    P820033

    Owner / Operator

    Firm Name
    Asahi Kasei Medical Co., Ltd.
    Operator Number
    10040402
    Address
    1-1-2 Yurakucho
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    100-0006
    Country
    JP
    Correspondent
    Haruna Yamaki

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma MDP

    Proprietary Names

    Plasmaflo OP-05W(A)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)