Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003678543

FEI Number

3003678543

Entity Name

Biomerics Alajuela

City/State/Country

ALAJUELA, CR

Establishment Address

SARET INDUSTRIAL PARK, BLDG. D-3, C-1, C-7, C-2/C-3, C-4, E-2, ALAJUELA 4002, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biomerics (Owner Number: 10042380)

Owner / Operator Contact Address

6030 W Harold Gatty Drive, Salt Lake City, UT 84116, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-11
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-12-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-10-18
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-11
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-12-11
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-12-11
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2023-12-11
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-11
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2023-12-11
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-12-11
QJA	Tympanostomy Tube Delivery Product With Drug	Unknown	Class 3	N/A	2024-04-16
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-09-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-08-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-12-11
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-04-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-11
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-11
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-11
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-12-11
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-09-17
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-12-11
QGK	Balloon, Nasal Airway	Ear, Nose, Throat	Class 1	874.4420	2023-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-11
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2026-05-29
PUM	Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	Cardiovascular	Class 2	870.1251	2023-12-11
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2023-12-11
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2023-12-11
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-09-17
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2024-09-17
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2023-12-11
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-12-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-07-05
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-07-05
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2023-12-11
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-09-18
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-12-11
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2023-12-11
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-12-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-12-11
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-09-17
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2024-10-18
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2024-09-17

Official Correspondent

Jacob Wakley

US Agent Details

Jake Wakley Business: Biomerics Email: jwakley@biomerics.com Phone: (801) 3552705

Related Public Records

Same Entity

Biomerics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016079756	Biomerics NLE	Monroe, CT, US
3026390991	Biomerics Dominican Republic	Haina San Cristobal, DO
3014246639	Biomerics Cartago	Cartago, CR
3012159165	BIOMERICS Advanced Catheter	Brooklyn Park, MN, US
3008998256	BIOMERICS	Salt Lake City, UT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200041	Fiagon GmbH	FlexPointer 1.5 Single Use, FlexTube 3 Single Use	2020-03-10
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003678543. Last updated year: 2026. Please use registration number 3003678543 when referencing this establishment in official correspondence.