BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    HUNG CHUN BIO-S CO., LTD.

    Reg #: 3009761487 · FEI: 3009761487 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HUNG CHUN BIO-S CO., LTD.
    Registration Number
    3009761487
    FEI Number
    3009761487
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.12, Luke 1st Rd., Luzhu Dist., Southern Taiwan Science Park
    City
    Kaohsiung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K172821

    Owner / Operator

    Firm Name
    HUNG CHUN BIO-S CO., LTD.
    Operator Number
    10041652
    Address
    No.12, Luke 1st Rd., Luzhu Dist., Southern Taiwan Science Park
    City
    Kaohsiung City
    State
    TW-NOTA
    Postal Code
    821
    Country
    TW
    Correspondent
    Hung-Chun Cheng

    US Agent

    Business Name
    ROC Chinese-European Industrial Research Society
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    TIONE TS Dental Implant System Ti-One 101 Dental Implant System TIONE 101 Dental Implant System Final Drill (Long/Short), Mini Final Drill, Final Drill Stopper, Tap, TS Tap, Mucosa Punch Hex Driver, Ratchet Hex Driver, Mini Ratchet Hex Driver, Screwman Ratchet Hex Driver Ratchet Adapter, Mini Ratchet Adapter, Handpiece Adapter, Mini Handpiece Adapter, Tap Adapter Extender, Torque Ratchet, Mini Scanbody Lance, Mini Lance Drill, Lindemann, Pilot Drill, Round drill, Countersink, Mini Countersink Drill Bone Condenser (Straight/Curved) Guide Pin, Mini Guide Pin, Mini Angled Guide Pin, Path Pin, Depth Gauge

    Establishment Types

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