BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LABORIE MEDICAL TECHNOLOGIES CORP.

    Reg #: 3017448360 · FEI: 3017448360 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    53
    Establishment Types
    4
    Classifications
    12

    Registration Details

    Registration Name
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Registration Number
    3017448360
    FEI Number
    3017448360
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    180 International Drive
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090830

    Owner / Operator

    Firm Name
    Laborie Medical Technologies Corp.
    Operator Number
    10079684
    Address
    180 International Drive
    City
    Portsmouth
    State
    NH
    Postal Code
    03801
    Country
    US
    Correspondent
    Nicole Boser

    Products

    Device Name Product Code
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Perineometer HIR
    System, Gastrointestinal Motility (Electrical) FFX
    Stimulator, Electrical, Evoked Response GWF
    Device, Nerve Conduction Velocity Measurement JXE
    Device, Cystometric, Hydraulic FEN
    Medical Device Data System OUG
    Uroflowmeter EXY
    System, Image Processing, Radiological LLZ
    Monitor, Esophageal Motility, Anorectal Motility, And Tube KLA
    Cystometer, Electrical Recording EXQ

    Proprietary Names

    injeTAK Adjustable Tip Needle Tube for Vaginal Sensor UROSTYM Biofeedback Probes Tube for Anal Sensor Injetak UROSTYM Biofeedback and Stimulation Probes GI Catheters (electrical) Solar Compact Ohmega Solar GI with MMP Plus GI System (Electrical) Solar GI 8-Channel Perfusion Set 8-Channel Radial Anorectal Catheter 4-Channel Radial Anorectal Catheter 4-Channel Radial ARM Catheter Ano-rectal Manometry Option (ARM) 4-Channel Perfusion Set Solar GI with Neuro Module I-LIST HL7 Engine UROSTYM Biofeedback And Stimulation Device and Accessories Urocap IV Urocap NXT Urocap V Urocap III Urocap IV Light Goby NXT Aquarius Solar GI with CIM-AUX Solar GI with MMS Video Option T-DOC Air-Charged Single Sensor Catheter Air-Charged Catheters Coude Dual Lumen Catheter Abdominal Pressure Catheter T-DOC Air-Charged Dual Sensor Catheter Bladder Pressure Catheter T-DOC Air-Charged Abdominal Sensor Catheter T-DOC Air-Charged Catheter Pump Tubing Infusion Line Air-Charged Reusable Cable Cystometry Pack Electrodes Infusion Pump Tube Set Urodynamic Measurement Tubing e•Sense® Urodynamic Catheters Solar Blue, Nexam Urodynamic Catheters SOLAR Anorectal Manometry Catheter Urodynamic Pump Infusion Tubing Pump Tube Set Flowmaster, Flowstar UROSTYM Biofeedback and Stimulation Device

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device