BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Biomerics Alajuela

    Reg #: 3003678543 · FEI: 3003678543 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    76
    Establishment Types
    1
    Classifications
    31

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    Registration Details

    Registration Name
    Biomerics Alajuela
    Registration Number
    3003678543
    FEI Number
    3003678543
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SARET INDUSTRIAL PARK, BLDG. D-3, C-1, C-7, C-2/C-3, C-4, E-2
    City
    ALAJUELA
    Country
    CR

    Owner / Operator

    Firm Name
    Biomerics
    Operator Number
    10042380
    Address
    6030 W Harold Gatty Drive
    City
    Salt Lake City
    State
    UT
    Postal Code
    84116
    Country
    US
    Correspondent
    Jacob J Wakley

    US Agent

    Business Name
    Biomerics
    Contact Name
    Jake Wakley
    Address
    6030 W Harold Gatty Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84116
    Country
    US
    Email
    [email protected]
    Phone
    801 3552705

    Products

    Device Name Product Code
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Orthopedic Stereotaxic Instrument OLO
    Catheter, Intravascular, Diagnostic DQO
    Instrument, Ent Manual Surgical LRC
    Drain, Tee (Water Trap) BYH
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Tympanostomy Tube Delivery Product With Drug QJA
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Set, I.V. Fluid Transfer LHI
    Arthroscope HRX
    Set, Administration, Intravascular FPA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Screw, Fixation, Bone HWC
    Balloon, Nasal Airway QGK
    System, Facet Screw Spinal Device MRW
    Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures PUM
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Cannula, Sinus KAM
    Mechanical Thrombolysis Catheter QEY
    Electrode, Circular (Spiral), Scalp And Applicator HGP
    System, X-Ray, Tomography, Computed JAK
    Bronchoscope (Flexible Or Rigid) EOQ
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Unit, Cryosurgical, Accessories GEH
    Bronchoscope Accessory KTI
    Eustachian Tube Balloon Dilation Device PNZ
    Powered Surgical Instrument For Improvement In The Appearance Of Cellulite OUP
    Cement, Bone, Vertebroplasty NDN
    Bone Cement LOD
    Tube, Tympanostomy ETD

    Proprietary Names

    TriDi Probe Cage-X CORUS Navigation Access System NavWire Soft-Vu Angiographic Catheters Ultirra Nav Water Trap TruDi Shaver Blade Scout Tula Earplug 10-Pack Size 1 Tula Earplug 10-Pack Size 2 Tula TDS 1.14 Grommet Tula Earplug 10-Pack Size 4 Tula Control Unit Spare Tula Earplug 10-Pack Size 6 Tula Kit - Unilateral Tula Earplug Sizers Tymbion and Syringe Pack TYMB001 Tula Earplug 10-Pack Size 3 Tula Earset Spare Tula Kit - Bilateral Tula Earplug 10-Pack Size 5 SmartPort Plastic SmartPort+ HyHub Duo Vial Access Device CORUS Spinal System-X Smart Port CT Lifeguard Infusion Set RFS2 Stylet TruDi Currette Bone Screw SpinPlus Nav Xcela Plus Port with PASV Valve Technology Xcela Plus Port BioFlo Port with ENDEXO Technology BioFlo Port with ENDEXO and PASV Valve Technology Spin Plus Relieva Tract VivAer Stylus CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) Sentinel Subassembly Decanav Mapping Catheter SideKick LP, 5pk Flex BIOFLO PORT WITH ENDEXO AND PASV VALVE TECHNOLOGY BIOFLO PORT WITH ENDEXO TECHNOLOGY Uni-Fuse+ Infusion System Quick Connect Spiral Electrode Relieva Ultirra Monarch Cytology Brush Monarch Bronchoscope Patient Introducer Kit Autoinjector XSense Cryoablation System with Cryoprobes TruDi NavWire 5pk Luma Sentry Patient Introducer Cytology Brush Vortex LP Vascular Access Port PMT PCSS Pulse Spray Infusion System UniFuse Infusion System Airway Elliot RhinAer Stylus 2 Aveli Precision Cellulite Release Device (Borealis) Aveli Precision Cellulite Release Device (Ceres) RhinAer Stylus TruDi Smart Port CT Low Profile Smart Port CT Mini Accu-Vu Sizing Catheters Kiva CORUS-LX Implant 4mm CORUS-LX Implant 5mm Tula Tympanostomy Tube Delivery Device CAVUX FFS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)