BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    QUANTA SYSTEM, S.P.A.

    Reg #: 3004378299 · FEI: 3004378299 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    148
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    QUANTA SYSTEM, S.P.A.
    Registration Number
    3004378299
    FEI Number
    3004378299
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA ACQUEDOTTO, 109
    City
    SAMARATE Varese
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K180922

    Owner / Operator

    Firm Name
    QUANTA SYSTEM, S.P.A.
    Operator Number
    9057522
    Address
    via Acquedotto 109, --
    City
    Samarate
    State
    Varese
    Postal Code
    21017
    Country
    IT
    Correspondent
    Dario Bandiera

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Tray, Surgical, Instrument FSM
    Laparoscope, General & Plastic Surgery GCJ
    Extractor, Vacuum, Fetal HDB
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN

    Proprietary Names

    Olympus Empower H100 Suprema 4V Suprema VT Domino Suprema Duetto Suprema Suprema VT+ Surgical Tray 71/4FOQS Fiber Dust PRO Thunder HR Thunder Thunder VT OptiScan TH Echo Cyber Blade Chrome Disposable Specimen Cup Litho CYBER TM 200 CYBER TM 150 OAF005501 OAF002011 OAF009911 OAF008011 OAF005511 OAF008001 OAF002711 OAF009901 OAF003611 OAF003601 OAF006001 OAF006011 OAF002001 OAF002701 OAF402011 OAF703691 OAF703611 OAF702791 OAF402711 OAF702701 OAF702711 OAF703601 OAF302711 OAF302721 OAF102791 OAF103611 OAF102711 OAF103691 Twain 2940 OAF002703 OAF006003 OAF002003 OAF003603 OAF005513 OAF402013 OAF702793 OAF006013 OAF008013 OAF002013 OAF402713 OAF703603 OAF009913 OAF002713 OAF702703 OAF005503 OAF003613 OAF008003 OAF009903 OAF702713 OAF703693 OAF703612 OAF002712 OAF702712 OAF009912 OAF402712 OAF002012 OAF005512 OAF008012 OAF402012 OAF102793 OAF102713 OAF103613 OAF103693 OAF703613 Discovery Pico Derm Discovery Pico Discovery Pico Plus EMP-FBX365HS EMP-FBX200BHS EMP-FBX200HS EMP-FBX1000HS EMP-FBX272HR-C EMP-FBX550HS EMP-FBX200BHS-C EMP-FBX272HR EMP-FBX272HS-C EMP-FBX550HR EMP-FBX1000HR EMP-FBX200HR EMP-FBX272HS EMP-FBX365HR Light A Twain IPL MDK 3 Q-PLUS R Q-Plus C LIGHT A Star LIGHT 4V Q-PLUS A LIGHT B DOMINO MDK 1 MDK 2 LIGHT C Duality Litho Evo Single Use CO2 Laser Fiber Opera Evo Youlaser PRIME Youlaser PRIME MT Youlaser PRIME CO2 Litho 150 Litho 60 Litho 100 Rosso Olympus Empower H35 Cryo6 LITHO DK30 Venacure 1470 Pro STUDIO ASSET Fiber Dust Olympus Empower H65 OptiScan Youlaser Co2 LITHO Nanostar Y Nanostar C Nanostar R 585 EliteScan DenaVe OAF506011 OAF506001 OAF506091 OFA001511 Accure CryoMini X3 MULTIFUNCTIONAL TROLLEY FOR QUANTA SYSTEM

    Establishment Types

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