BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Novanta Medical GmbH

    Reg #: 8043980 · FEI: 3002914049 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    73
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    Novanta Medical GmbH
    Registration Number
    8043980
    FEI Number
    3002914049
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ALTE POST STR. 11
    City
    LUDWIGSSTADT Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K030837

    Owner / Operator

    Firm Name
    Novanta Medical GmbH
    Operator Number
    9004880
    Address
    Siemensdamm 58, --
    City
    Berlin
    State
    DE-BE
    Postal Code
    13627
    Country
    DE
    Correspondent
    Silke - Lucht

    US Agent

    Business Name
    NOVANTA MEDICAL USA, INC.
    Contact Name
    Aylin Ng Saye
    Address
    100 Paramount Dr Ste 101
    City
    Sarasota
    State
    FL
    ZIP
    34232
    Country
    US
    Email
    [email protected]
    Phone
    407 4388810

    Products

    Device Name Product Code
    Instrument, Special Lens, For Endoscope FEI
    Insufflator, Laparoscopic HIF
    Insufflator, Endoscopic Vessel Harvesting OSV
    Laparoscope, General & Plastic Surgery GCJ
    System, Digital Image Communications, Radiological LMD
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Insufflator, Hysteroscopic HIG
    Device, Digital Image Storage, Radiological LMB
    Probe, Uptake, Nuclear IZD
    Laparoscope, Gynecologic (And Accessories) HET
    Cover, Barrier, Protective MMP
    Arthroscope HRX
    Camera, Surgical And Accessories KQM
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM

    Proprietary Names

    Autoclavable Fixed Focal Lenght Coupler C-Mount HD Optical Zoom Coupler Autoclavable HD-Zoom Coupler Synergy Insufflation 40 L High Flow Insufflator F108, F107, F104 and F112 Heated High-Flow Tube Set Smoke Evacuation High-Flow Tube Set High-Flow Tube Set Heated Humidified Smoke Evacuation Tube Set Pneumoclear ZeroWire or ZeroWire G2 PNEUMO SURE HIGH FLOW INSUFFLATOR PNEUMO SURE XL HIGH FLOW INSUFFLATOR 45L Core Insufflator F114 ConductOR ND3, Connect OR ScaleOR ExpandOR high pressure hose for bottle gas supply CO2 gas connectors hoses for central gas supply Insufflator 50L SynergyInsufflation IUR FLUID MANAGEMENT SYSTEM Evolution4K GAMMA FINDER III Irrigation Pump Unit AQL-100PBS Multiple Fluid Monitoriing Unit AQL-100CBS AQUILEX FLUID CONTROL SYSTEM AQL-100S Tube Set for Vacuum incl. Filter HysteroLux Fluid Management System Scale Tube Set for Suction, single-use HysteroLux Fluid Management System Control Unit Tube Set for Suction (with 2 ports), single-use GYN-Pump PH304 Fluid Monitoring Unit PS304 Tube Set for Irrigation, single-use Lap Wave 3000, P07 and P101 1031 Sterile Sleeve, GAMAA FINDER III LAP-Pump PP110 LAP-Pump PP120 PUREVUE FMS Day use tube set for irrigation, pump part, 10 applications Tube set for suction, 2-lines, single-use Tube set for suction, single-use Tube set for vacuum, incl. filter, 30-day use Double pedal foot switch Autoclavable remote control Tube set for irrigation, single-use Patient tube for irrigation, single-use Tube set inflow 4-Spike adaptor AirSeal iFS System RADIANCE Vital Screen LifeVue Evolution family ND-Cam ENDOVUE GX5MP PUMP, FLUID SAFE FLUID MANAGEMENT SYSTEM 2222 Hystero Pump II Flocontrol -Arthroscopy Pump Model 150 Arthroscopy Pump A107 and A114 HysteroFlow II / HysteroBalance II GoFlo Pump A127 Pump for Arthroscopy A127 FloSteady Flosimple Arthroscopy Pump A120 and A119 Da Vinci Insufflator Tube Set - Smoke Evacuation Da Vinci Insufflator CAMERA HEAD AC - C-MOUNT COUPLER AC ZOOM

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device