BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SUN MEDICAL CO., LTD.

    Reg #: 8030419 · FEI: 3002973484 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SUN MEDICAL CO., LTD.
    Registration Number
    8030419
    FEI Number
    3002973484
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    571-2 Furutaka-cho
    City
    Moriyama Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K254063

    Owner / Operator

    Firm Name
    SUN MEDICAL CO., LTD.
    Operator Number
    10094760
    Address
    571-2 Furutaka-cho
    City
    Moriyama
    State
    Shiga
    Postal Code
    524-0044
    Country
    JP

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    iCEM Universal Plus

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device