BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MucoPEG

    Reg #: 3013534361 · FEI: 3013534361 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SUNBIO,INC.
    Registration Number
    3013534361
    FEI Number
    3013534361
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    95, Sanbon-ro, SunBio, Inc.
    City
    Gunpo-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K190144

    Owner / Operator

    Firm Name
    SunBio,Inc.
    Operator Number
    10083497
    Address
    95, Sanbon-ro, SunBio, Inc.
    City
    Gunpo-si
    State
    Gyeonggi
    Postal Code
    15849
    Country
    KR

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Saliva, Artificial LFD

    Proprietary Names

    MucoPEG

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198