Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014032451

FEI Number

3014032451

Entity Name

UTITEC MEDICAL S.A.

City/State/Country

El Coyol Alajuela, CR

Establishment Address

Zona Franca Coyol, Alajuela., Building N. 15, El Coyol Alajuela 506, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Utitec Medical S.A. dba Cadence Costa Rica (Owner Number: 10056426)

Owner / Operator Contact Address

Zona Franca Coyol, Alajuela., Building N. 15.3, Coyol, CR-A 20113, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Brevera Biopsy System with CorLumina Technology Brevera Breast Biopsy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-12-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Hegedus Business: Cadence Inc Email: robert.hegedus@cadenceinc.com Phone: (412) 5764676

Related Public Records

Same Entity

Utitec Medical S.A. dba Cadence Costa Rica

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3017450165	NANICE MEDICAL SOLUTIONS, LLC	Flourtown, PA, US
1526711	ISOMEDIX OPERATIONS INC	GROVEPORT, OH, US
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US
3010011359	BIORAD MEDISYS PVT. LTD.	Pune Maharashtra, IN
9611278	Stengelin Medical GmbH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014032451. Last updated year: 2026. Please use registration number 3014032451 when referencing this establishment in official correspondence.