BEUDAMED
    FDA Registration Active 🇲🇨 Monaco

    ROCAMED SAM

    Reg #: 3016096097 · FEI: 3016096097 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    ROCAMED SAM
    Registration Number
    3016096097
    FEI Number
    3016096097
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9 Avenue Albert II, Le copori
    City
    MONACO Monaco-Ville
    Country
    MC

    Regulatory Submissions

    510(k) Number
    K182144

    Owner / Operator

    Firm Name
    ROCAMED SAM
    Operator Number
    10092141
    Address
    9 Av Albert II
    City
    MONACO
    State
    Monaco-Ville
    Postal Code
    98000
    Country
    MC
    Correspondent
    Erica Tartaglione

    Products

    Device Name Product Code
    Accessories, Catheter, G-U KNY
    System, Evacuator, Fluid FHF
    Endoscopic Irrigation/Suction System OCX
    Powered Laser Surgical Instrument GEX
    Catheter, Irrigation GBX
    Stylet, Ureteral EYA
    Needle, Aspiration And Injection, Disposable GAA
    Stent, Ureteral FAD
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Catheter, Ureteral, Gastro-Urology EYB

    Proprietary Names

    Bi-Flex Evo Irrigation/Aspiration set ENDOFLOW II - Irrigation, Warming and Suction System Laser Thermal Therapy Kit Catheter for irrigation, irrigation line; Endoscopic irrigation line TraxerFlow, double spikes, with flushing pump, univ Rocamed RocaWire Guidewires; Roca Wire Rio Tracer Echolaser Smart Interface JFil Ureteral Stents, JFil Ureteral Stents ECO KIT RocaJJ Soft Stents ROCAMED RocaStone Stone Extractors RocaTub Ureteral Catheter ECHOLASER X4 ELESTA S.P.A

    Establishment Types

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