BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    FRENDTM System

    Reg #: 3009092698 · FEI: 3009092698 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NANOENTEK INC
    Registration Number
    3009092698
    FEI Number
    3009092698
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12F, 5, Digital-ro 26-gil, Guro-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K124056

    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
    Fluorometer, For Clinical Use KHO
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ

    Proprietary Names

    FRENDTM System FRENDTM PSA Plus

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility