BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    MACROMEDICS BV

    Reg #: 3010701021 · FEI: 3010701021 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    MACROMEDICS BV
    Registration Number
    3010701021
    FEI Number
    3010701021
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Oostbaan 670
    City
    Moordrecht Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K250429

    Owner / Operator

    Firm Name
    MacroMedics BV
    Operator Number
    10046168
    Address
    Oostbaan 670
    City
    Moordrecht
    State
    Zuid-Holland
    Postal Code
    2841ML
    Country
    NL
    Correspondent
    J. Drenth

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Mask DSPS®-PROS, set/5 DSPS-Prominent® Cradle-II DSPS-Prominent® baseplate, MR DSPS-Prominent® baseplate DSPS-Prominent® Cradle-VI DSPS PRO Mask Shim Set HNS Mask DSPS®-PROSCL set/5 DSPS PRO Mask Shim Set HO DSPS-Prominent® Cradle-IV Mask DSPS®-PROSH set/5 DSPS-Prominent® SH profile set/2 Mask DSPS®-PROSVR, set/5 Handgrips HNS, set/2 DSPS®-PRO Coil Ref Tool Mask DSPS®-PROSHL set/5 Mask DSPS®-PROSCVRL set/5 DSPS-Prominent® Cradle-III Mask DSPS®-PROSC set/5 Mask DSPS®-PROH, set/5 DSPS-Prominent® Cradle-I Mask DSPS®-PRO, set/5 DSPS-Prominent® Cradle-VII Mask DSPS®-PROSHVRL set/5 Mask DSPS®-PROSL, set/5 Mask DSPS®-PROSCVR set/5 Mask DSPS®-PROSVRL, set/5 Mask DSPS®-PROSHVR set/5 BreastBoard SX FlexBoard EagleBoard CouchStripCS53FGF-PRO CouchStrips VacuumCushions LEPS FeetSupports Patient Positioning Devices

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device