Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014246639

FEI Number

3014246639

Entity Name

Biomerics Cartago

City/State/Country

Cartago, CR

Establishment Address

Edificio 22-23 A to D and A4, Zona Franca Parque Industrial Zeta, Cartago 30106, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biomerics (Owner Number: 1833117)

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

Coiled Extension Tubing Transfer Sets BNLE Access Guidewire Total Abscession Biliary Drainage Catheter Monarch Bronchoscope Monarch Bronchoscope Inlay Optima Ureteral Stent Extension Lines with Dual Check Valves Total Abscession General Drainage Catheter Straight Extension Line Total Abscession General Drainage Catheter Alatus Vaginal Balloon Packing System TalWire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-12-26
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2020-12-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-09-24
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2024-09-19
QNW	Reprocessed Bronchoscope	Ear, Nose, Throat	Class 2	874.4680	2025-02-05
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-03-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-03-07
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2023-06-29
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2021-01-08
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-09-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-02-09
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2024-09-19
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-04-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-09-24

Official Correspondent

Jake 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
3012159165	BIOMERICS Advanced Catheter	Brooklyn Park, MN, US
3008998256	BIOMERICS	Salt Lake City, UT, US
3003678543	Biomerics Alajuela	ALAJUELA, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
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
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014246639. Last updated year: 2026. Please use registration number 3014246639 when referencing this establishment in official correspondence.