Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613793

FEI Number

3006469671

Entity Name

DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.

City/State/Country

LA AURORA, HEREDIA, CR

Establishment Address

GLOBAL PARK, 602 PARKWAY, LA AURORA, HEREDIA 146, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. (Owner Number: 9032613)

Owner / Operator Contact Address

GLOBAL PARK, P.O. BOX 180-3006, 602 PARKWAY, LA AURORA, HEREDIA, CR-NOTA 146, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thermometer, Electronic, Clinical - DeRoyal VARIOUS FOLEY CATHETERS Catheter, Upper Urinary Tract - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Stethoscope, Esophageal, with Electrical Conductors - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Incubator, Neonatal - Warmer, Infant Radiant - DeRoyal Gauze/Sponge, nonresorbable for external use - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Electrosurgical, cutting & coagulation & Accessories - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Device, Occlusion, Umbilical - DeRoyal Warmer, Infant Radiant - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Stethoscope, Esophageal, with Electrical Conductors - DeRoyal Arthroscope - DeRoyal Cutter, Surgical - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Arthroscope - Electrosurgical, Cutting & Coagulation & Accessories DeRoyal Electrocautery, Gynecologic (and Accessories)- DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-11-28
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2005-09-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-01-26
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2020-04-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-02-10
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2005-09-14
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2005-09-14
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2005-09-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-05-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-10
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2020-11-19
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2013-06-05
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2020-07-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-11-13
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2005-09-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-02-10
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-09-20
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2016-11-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-05-30
EYC	Catheter, Upper Urinary Tract	Gastroenterology, Urology	Class 2	876.5130	2016-04-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-05-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-09-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-02-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-01-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-27
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2016-01-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-12-30

Official Correspondent

No official correspondent registered.

US Agent Details

Elizabeth Reed Business: DeRoyal Industries, Inc. Email: ereed@deroyal.com Phone: (865) 3621256

Related Public Records

Same Entity

DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0041-2020	Ohmeda Medical	2	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0008-2013	Gynex Corporation	2	Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "*GYNEX* Electrode Handpiece, Foot Activated* Manufactured for GYNEX*" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613793. Last updated year: 2026. Please use registration number 9613793 when referencing this establishment in official correspondence.