BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUJIFILM Healthcare Americas Corporation

    Reg #: 3005625991 · FEI: 3005625991 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    FUJIFILM Healthcare Americas Corporation
    Registration Number
    3005625991
    FEI Number
    3005625991
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1100 King Georges Post Rd
    City
    Edison
    State
    NJ
    ZIP
    08837
    Country
    US

    Regulatory Submissions

    510(k) Number
    K871763

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    Address
    26-30, Nishiazabu 2-chome
    City
    MINATO-KU
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Calibrator, Multi-Analyte Mixture JIX
    Micro Total Analysis Instrument System OUE
    Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma OAU
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment NSF
    Calibrator, Primary JIS

    Proprietary Names

    NEFA Standard Solution Multi-Calibrator Lipids uTASWako DCP uTASWako AFP-L3 NEFA Linearity Material Wako HDL-C/LDL-C Calibrator

    Establishment Types

    Repack or Relabel Medical Device