BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Fluorescence Imaging Kit

    Reg #: 3015153469 · FEI: 3015153469 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DTG Medical Pte Ltd
    Registration Number
    3015153469
    FEI Number
    3015153469
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    438B Alexandra Road #06-03, Alexandra Technopark Tower B
    City
    Petro Centre Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K141077

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    System, X-Ray, Angiographic IZI
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Fluorescence Imaging Kit 8mm 30 degree endoscope 8mm 0 degree endoscope

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device