BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Da Vinci Insufflator Tube Set - Smoke Evacuation

    Reg #: 3033043422 · FEI: 3033043422 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NOVANTA MEDICAL S.R.O.
    Registration Number
    3033043422
    FEI Number
    3033043422
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pardubicka 1571
    City
    Prelouc Pardubicky Kraj
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K232610

    Owner / Operator

    Firm Name
    Novanta Medical s.r.o.
    Operator Number
    10092454
    Address
    Pardubicka 1571
    City
    Prelouc
    State
    Pardubicky Kraj
    Postal Code
    535 01
    Country
    CZ
    Correspondent
    Sofia Panagou

    US Agent

    Business Name
    NDS SURGICAL IMAGING, LLC
    Contact Name
    Michael Reents
    Address
    100 Paramount Dr Ste 101
    City
    Sarasota
    State
    FL
    ZIP
    34232
    Country
    US
    Email
    [email protected]
    Phone
    941 7462413

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Insufflator, Laparoscopic HIF

    Proprietary Names

    Da Vinci Insufflator Tube Set - Smoke Evacuation

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)