BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    EVO 501K TL, EVO 501K ML, EVO 501N ML, EVO 501N M, EVO 501MW ML, EVO 501ST ML, EVO 501ST M

    Reg #: 3010364969 · FEI: 3010364969 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TTBIO CORPORATION
    Registration Number
    3010364969
    FEI Number
    3010364969
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, NO.7, 6TH ROAD INDUSTRY PARK
    City
    TAICHUNG
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K141183

    Owner / Operator

    Firm Name
    TTBIO CORPORATION
    Operator Number
    10044279
    Address
    2F, NO.7, 6TH ROAD INDUSTRY PARK
    City
    TAICHUNG
    State
    TW-NOTA
    Postal Code
    40755
    Country
    TW
    Correspondent
    Sheng-Chieh Su

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    EVO 501K TL, EVO 501K ML, EVO 501N ML, EVO 501N M, EVO 501MW ML, EVO 501ST ML, EVO 501ST M 101 3M4, 101 3T4 500T+, 500TL+, 500M+, 500 ML+, 500K T+, 500K TL+, 500K M+, 500K ML+, 500N T+, 500N TL+, 500N M+, 500N ML+ EZclick-L, EZclick-LED, EZclick-KL, EZclick-KLED, EZclick-NL, EZclick-NLED SABLE ROTAMAX PRO KL, SABLE ROTAMAX PRO NL, SABLE ACCESS PRO KL, SABLE ACCESS PRO NL EZclick, EZclick-K, EZclick-N Turbo Torque 2400, Turbo Torque 2200, Turbo Torque 2200N Viper 3 17-205, Viper 3 17-195 ECO 105, ECO 101 4T4, ECO 101 4M4

    Establishment Types

    Manufacture Medical Device