BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SUNBIO,INC.

    Reg #: 3013534361 · FEI: 3013534361 · Expires 2026
    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
    2026
    Initial Importer
    No
    Address
    129 Eunbong-ro, Namdong-gu
    City
    Incheon-si
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K190144

    Owner / Operator

    Firm Name
    SunBio,Inc.
    Operator Number
    10083497
    Address
    129 Eunbong-ro, Namdong-gu
    City
    Incheon-si
    State
    KR-28
    Postal Code
    21639
    Country
    KR
    Correspondent
    Kwang Nho

    Products

    Device Name Product Code
    Saliva, Artificial LFD

    Proprietary Names

    MucoPEG

    Establishment Types

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