BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SERIM RESEARCH CORP.

    Reg #: 1833387 · FEI: 1833387 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    SERIM RESEARCH CORP.
    Registration Number
    1833387
    FEI Number
    1833387
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3506 Reedy Dr
    City
    ELKHART
    State
    IN
    ZIP
    46514
    Country
    US

    Regulatory Submissions

    510(k) Number
    K914123

    Owner / Operator

    Firm Name
    SERIM RESEARCH CORP.
    Operator Number
    9001543
    Address
    3506 REEDY DR., --
    City
    Elkhart
    State
    IN
    Postal Code
    46514
    Country
    US

    Products

    Device Name Product Code
    Dialyzer Reprocessing System LIF
    Indicator, Physical/Chemical Sterilization Process JOJ
    Subsystem, Water Purification FIP
    Detector, Leak, Blood FJD
    Sterilant, Medical Devices MED
    Test, Urine Leukocyte LJX
    Helicobacter Pylori LYR
    Strip, Dialysate Ph Indicator MNV
    Strip, Test, Reagent, Residuals For Dialysate, Disinfectant MSY
    Filter, Blood, Dialysis FKJ

    Proprietary Names

    Formaldehyde Formaldehyde Test Serim GUARDIAN HiSENSE OPAL Serim GUARDIAN Blood Leak Serim DISINTEK GTA 1.5% Test Strips Serim DISINTEK OPA Test Strips Serim GUARDIAN Residual Peroxide Serim PeriScreen Test Strips Serim PyloriTek Reagent Strips Serim GUARDIAN BICARB pH II Serim GUARDIAN HiSENSE Ultra 0.1 Test Strips Serim GUARDIAN Peracetic Acid Serim GUARDIAN Residual Chlorine Serim Residual Chlorine Test Strips

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only