BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    T&R BIOFAB CO.,LTD.

    Reg #: 3016901080 · FEI: 3016901080 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    T&R BIOFAB CO.,LTD.
    Registration Number
    3016901080
    FEI Number
    3016901080
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    96, Mayu-ro
    City
    Siheung-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222057

    Owner / Operator

    Firm Name
    T&R BIOFAB CO.,LTD.
    Operator Number
    10082367
    Address
    96, Mayu-ro
    City
    Siheung-si
    State
    Gyeonggi
    Postal Code
    15111
    Country
    KR
    Correspondent
    Wonsoo Yun

    US Agent

    Business Name
    Lighten Bridge LLC
    Contact Name
    Edward PARK
    Address
    4408 Tortuga Ln
    City
    Mc Kinney
    State
    TX
    ZIP
    75070
    Country
    US
    Email
    [email protected]
    Phone
    972 8000044

    Products

    Device Name Product Code
    Dressing, Wound, Hydrophilic NAC
    Tape And Bandage, Adhesive KGX
    Bandage, Liquid, Skin Protectant NEC
    Continuous Measurement Thermometer FLL
    Dressing, Wound, Occlusive NAD

    Proprietary Names

    SurgiAngel, SurgiCure Reproderm-gel TnR Foam A Band Bonofoam S Band Bonofoam A Band TnR Foam S Band SurgiCure S Elastonz-gel S SurgiAngel S Reproderm-gel S THERMOQUICK THERMOCARE THERMOCLICK Bonofoam Band Plus Bonofoam Band Bonofoam TnR Foam TnR Foam Band TnR Foam Band Plus

    Establishment Types

    Manufacture Medical Device