BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    FMI MEDISCH BV

    Reg #: 3010370500 · FEI: 3010370500 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    45
    Establishment Types
    2
    Classifications
    39

    Registration Details

    Registration Name
    FMI MEDISCH BV
    Registration Number
    3010370500
    FEI Number
    3010370500
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    De Brauwweg 17
    City
    Schiedam Zuid-Holland
    Country
    NL

    Owner / Operator

    Firm Name
    FMI Medisch BV
    Operator Number
    10043390
    Address
    De Brauwweg 17
    City
    Schiedam
    State
    Zuid-Holland
    Postal Code
    3125 AE
    Country
    NL

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Retractor GAD
    Growing Rod System PGM
    Plate, Fixation, Bone HRS
    Osteotome HWM
    Clamp HXD
    Bender HXW
    Probe HXB
    Pin, Fixation, Smooth HTY
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Screwdriver HXX
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Manual Instruments Designed For Use With Total Disc Replacement Devices QLQ
    Cement Obturator LZN
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Extractor HWB
    Tap, Bone HWX
    Orthopedic Manual Surgical Instrument LXH
    Spinal Vertebral Body Replacement Device MQP
    Bit, Drill HTW
    Laparoscope, General & Plastic Surgery GCJ
    Laparoscopic Single Port Access Device OTJ
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Driver, Prosthesis HWR
    Guide, Surgical, Instrument FZX
    Pliers, Surgical HTC
    Brace, Drill HXY
    Caliper KTZ
    Instrument, Manual, Surgical, General Use MDM
    Thoracolumbosacral Pedicle Screw System NKB
    Reamer HTO
    Awl HWJ
    Ankle Fusion Cage SAI
    Rod, Fixation, Intramedullary And Accessories HSB
    Template HWT
    Rasp, Surgical, General & Plastic Surgery GAC

    Proprietary Names

    Vanguard PFR PEDICLE PROBE WITH BALL TIP MULTI-AXIAL SCREWDRIVER CANNULATED SCREWDRIVER T20 RATCHET SCREWDRIVER UNIVERSAL PEDICLE SCREWDRIVER ST MULTI AXIAL TRANSVERSE CONNECTOR ST ILIAC ROD LEFT SIDE ST ILIAC ROD RIGHT SIDE Prodisc C Nova; Prodisc C SK; Prodisc C Vivo Synplug Cervical Spine Truss System (CSTS) 7mm TAP 5mm TAP 12mm stop tap 6mm TAP Ø5mm CANNULATED TAP Ø7mm CANNULATED TAP Ø6mm CANNULATED TAP Cervical Spine Truss System (CSTS) Interbody Fusion Device INDEX RING FOR SETSCREW HOLDER CLIP INTRODUCER Pins for distractor/compressor Distractor / compressor Snap-on handle for drills Screw aligner VERTICALE WINX Blade Setscrew holder T30 SHAFT ROD GRIPPER U.L.I.S.™ UNIVERSAL SCREWDRIVER LUMIS UNIVERSAL SCREWDRIVER AXIAL ROD INTRODUCER / CLIP GUIDE - U1 - A337 New Fixed Angle Drill Guide AXIAL ROD INTRODUCER / CLIP GUIDE - U1 - A337N1 LONG SCREW FOR ROD PERSUADER Setscrew guide + Counter torque COUNTER TORQUE SCREW FOR ROD PERSUADER ROD PERSUADER Hexanium® TLIF Screw extender ENLARGED SCREW EXTENDER Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device CERVICAL SPINE TRUSS SYSTEM - STAND ALONE (CSTS-SA) INTERBODY FUSION DEVICE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility