BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SAIB Premium Condom

    Reg #: 3016246058 · FEI: 3016246058 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SAIB & CO INC.
    Registration Number
    3016246058
    FEI Number
    3016246058
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    73 Jandari-ro, 4F
    City
    Mapo-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K023059

    Owner / Operator

    Firm Name
    SAIB & CO INC.
    Operator Number
    10062187
    Address
    73 Jandari-ro, 4F
    City
    Mapo-gu
    State
    Seoul
    Postal Code
    04029
    Country
    KR

    US Agent

    Business Name
    Comvalis
    Contact Name
    Dean Baek
    Address
    2603 Camino Ramon Ste 200
    City
    San Ramon
    State
    CA
    ZIP
    94583
    Country
    US
    Email
    [email protected]
    Phone
    925 2422728

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    SAIB Premium Condom

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device