BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    NANOENTEK INC

    Reg #: 3007349751 · FEI: 3007349751 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    40
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    NANOENTEK INC
    Registration Number
    3007349751
    FEI Number
    3007349751
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    851-14, Seohae-ro, Paltan-myeon
    City
    Hwaseong Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    BK200525

    Owner / Operator

    Firm Name
    NanoEntek, Inc
    Operator Number
    10041714
    Address
    220 Bear Hill Road Suite 102
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    US Agent

    Business Name
    NanoEntek America, Inc.
    Contact Name
    Jacob Jung
    Address
    220 Bear Hill Road, Suite 102
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 4722558

    Products

    Device Name Product Code
    Reagent, Coronavirus Serological QKO
    Counter, Differential Cell GKZ
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Hemocytometer GHO
    General Purpose Reagent PPM
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Block, Heating JRG
    Fluorometer, For Clinical Use KHO
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Test, Residual, Wbc In Leukoreduced Blood MZG
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Vitamin D MRG
    Radioimmunoassay, Free Thyroxine CEC

    Proprietary Names

    FRCOA 020 COVID-19 total Ab Control LQ FREND COVID-19 total Ab with the FREND System ADAM-rWBC HT ADAM-rWBC Kit, ADHK-050 FREND System FREND TSH C-Chip DHC-M01 C-Chip DHC-B02 C-Chip DHC-F01 C-Chip DHC-N01 C-Chip DHC-N04 C-Chip DHC-N0420 C-Chip DHC-F0420 C-Chip DHC-B01 C-Chip DHC-B0420 C-Chip DHC-F04 C-Chip DHC-B04 ADAMII CD34 System FRBR 015 FREND Blocking Reagent FREND Testosterone FREND AP FRENDTM PSA Plus FRENDTM System r-Control RBC and PLT ADAM-rWBC2 (automatic white cell counter) AD1K-050 (ADAM-rWBC disposable kit) ADAMII-CD34 Kit ADAMII FREND Free T4 Linearity Kit FREND Testosterone Linearity Kit FREND PSA Plus Linearity Kit FREND Vitamin D Linearity Kit FREND TSH Linearity Kit F10 FREND 2 FREND PSA Plus FREND Vitamin D FREND Free T4

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198