BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    Haemonetics Cell Saver System

    Reg #: 9680437 · FEI: 3002808345 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KAWASUMI LABORATORIES (THAILAND) CO., LTD.
    Registration Number
    9680437
    FEI Number
    3002808345
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    55/26 MU 13, PHAHON YOTHIN RD.,, KM-46. TAMBON KHLONG NUENG,
    City
    KHLONG LUANG Pathum Thani
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K932890

    Owner / Operator

    Firm Name
    SB-KAWASUMI LABORATORIES, INC.
    Operator Number
    8031539
    Address
    3-25-4 Tonomachi, Kawasaki-ku
    City
    Kawasaki-shi
    State
    Kanagawa
    Postal Code
    210-8602
    Country
    JP
    Correspondent
    Kenichi - Inamura

    US Agent

    Business Name
    MIC International
    Contact Name
    Deno Zachary
    Address
    201 East 69th Street, Suite 5O,
    City
    New York
    State
    NY
    ZIP
    10021
    Country
    US
    Email
    [email protected]
    Phone
    917 3315789

    Products

    Device Name Product Code
    Apparatus, Autotransfusion CAC

    Proprietary Names

    Haemonetics Cell Saver System Haemonetics Cell Saver Elite System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)