BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Leltek Inc.

    Reg #: 3014555455 · FEI: 3014555455 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Leltek Inc.
    Registration Number
    3014555455
    FEI Number
    3014555455
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist.,
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K241161

    Owner / Operator

    Firm Name
    LELTEK
    Operator Number
    10074230
    Address
    6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist.,
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    23147
    Country
    TW
    Correspondent
    RA Leltek

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Stand, Infusion FOX

    Proprietary Names

    SuperSonic PocketVu Pivot Arm,Variable Height Mount Fixed and Variable Height Roll Cart, Roll Stand Patient Monitor Roll Stand, INFUSION Roll Stand, ECG Trolley, Pad Roll Stand, Medical Trolley, Display Trolley Computer Cart Patient Monitor Wall Mount, Wall Mount, Display Mount, Ventilator Arm, ECG Arm Endoscopy Cart Ultrasound Cart, Medical Cart, Nursing card, Display Cart, Equipment Cart

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device