BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    NEW DEANTRONICS TAIWAN LTD.

    Reg #: 9681191 · FEI: 3008207730 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    NEW DEANTRONICS TAIWAN LTD.
    Registration Number
    9681191
    FEI Number
    3008207730
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12F. No.51, Sec. 4, Zhongyang Rd., Tucheng Dist.,
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K982742

    Owner / Operator

    Firm Name
    NEW DEANTRONICS TAIWAN LTD.
    Operator Number
    9020358
    Address
    12F. No.51, Sec. 4, Zhongyang Rd., Tucheng Dist.
    City
    New Taipei City
    State
    TW-NOTA
    Postal Code
    236
    Country
    TW

    US Agent

    Business Name
    NEW DEANTRONICS, LTD.
    Contact Name
    TINA LO
    Address
    1 New Deantronics Way
    City
    Sparks
    State
    NV
    ZIP
    89441
    Country
    US
    Email
    [email protected]
    Phone
    775 4331808

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Software For Diagnosis/Treatment OSN
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Orthopedic Manual Surgical Instrument LXH
    Laparoscope, General & Plastic Surgery GCJ
    Automated External Defibrillators (Non-Wearable) MKJ
    Endoscope, Neurological GWG
    Instrument, Manual, Surgical, General Use MDM
    Apparatus, Exhaust, Surgical FYD
    Arthroscope HRX
    Electrode, Electrosurgical JOS
    Air-Handling Apparatus Accessory QGI

    Proprietary Names

    Rocker One Piece Pencil & Electrodes disposable handswitch pencil electrosurgical cutting and coagulation accessories electrosurgical pencil Suction Coagulator Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables smoke attachment extender foot control pencil Dist Rib Clear cannula with oburator cannula with oburator MACB Dual Slotted Cannula & Cannulated Trochar MI22 threaded clear cannula with oburator NANOSCOPE HANDPIECE REM patient return electrode patient return electrode Lucky Strike Neuroblade System Tip Cleaner Rocker Two Piece Pencil reusable clamp cord Coated Electrodes Hawkeye Control Unit with Eyas Endoscope Infant Return Pad Infant Return pad ESU Grounding pad - Adult Pad Lucky Strike Adapter VSMPA22 Telescopic Smoke Evacuation Button Switch Pencil Smoke Evacuation Button Switch Pencil

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)