BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    EVO 450Y, EVO 450YL, EVO 450 5H, EVO 450 4M

    Reg #: 3010364969 · FEI: 3010364969 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    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
    K190508

    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 450Y, EVO 450YL, EVO 450 5H, EVO 450 4M EVO 450W, EVO 450WL, EVO 450B, EVO 450BL, EVO 450MW, EVO 450MWL, EVO 450MR, EVO 450MRL EVO 450, EVO 450L, EVO 450K, EVO 450KL, EVO 450N, EVO 450NL, EVO 450S, EVO 450SL, EVO 450ST, EVO 450STL EVO 45M4 EVO 450 M4

    Establishment Types

    Manufacture Medical Device