Data / Medical devices / Costa Rica / Deroyal Cientifica De Latinoamerica S.R.L.

Deroyal Cientifica De Latinoamerica S.R.L.: FDA-registered device maker in La Aurora, Heredia, Costa Rica, 11 510(k) clearances

Name: Deroyal Cientifica De Latinoamerica S.R.L. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Deroyal Cientifica De Latinoamerica S.R.L. is registered with the FDA (registration 9613793) in La Aurora, Heredia, Costa Rica. It lists 17 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 31, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9613793
FEI number: 3006469671
Address: Global Park 602 Parkway, La Aurora, Heredia, Costa Rica, 146
Owner or operator: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. (9032613)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: September 14, 2005
Registered through: 2026
Brand names listed: Applicator, Absorbent Tipped, Sterile - DeRoyal, Arthroscope - DeRoyal, Arthroscope - Electrosurgical, Cutting & Coagulation & Accessories DeRoyal, Catheter, Upper Urinary Tract - DeRoyal, Cutter, Surgical - DeRoyal, Device, Occlusion, Umbilical - DeRoyal, Dissector, Surgical, General & Plastic Surgery - DeRoyal, Electrocautery, Gynecologic (and Accessories)- DeRoyal and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Repackager or relabeler	accessdata.fda.gov
Arthroscope	HRX	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Upper Urinary Tract	EYC	2	Contract manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Contract manufacturer	accessdata.fda.gov
Cutter, Surgical	FZT	1	Contract manufacturer	accessdata.fda.gov
Device, Occlusion, Umbilical	FOD	1	Contract manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Repackager or relabeler	accessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)	HGI	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	Contract manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Contract manufacturer	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Contract manufacturer	accessdata.fda.gov
Stethoscope, Esophageal, With Electrical Conductors	BZT	2	Contract manufacturer	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 31, 2018	K170703	Single Use Arthroscopic Electrode (with Pencil)	HRX	Substantially Equivalent	Modern Medical Equipment Manufacturing Limited	accessdata.fda.gov
August 12, 2008	K081647	ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS	GEI	Substantially Equivalent	Xodus Medical, Inc.	accessdata.fda.gov
May 6, 2005	K043036	NON-STICK ELECTRODE	GEI	Substantially Equivalent	Modern Medical Equipment Mfg., Ltd.	accessdata.fda.gov
December 17, 2002	K023986	ARTHREX OPES ELECTRODES AND ACCESSORIES	GEI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 13, 2002	K020579	AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03	GEI	Substantially Equivalent	Aaron Medical Industries	accessdata.fda.gov
September 3, 1996	K962935	UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE	GEI	Substantially Equivalent	Unimed Surgical Products, Inc.	accessdata.fda.gov
July 31, 1996	K952030	LOOP/SQUARE ELECTRODE	HGI	Substantially Equivalent	E & M Engineering, Inc.	accessdata.fda.gov
October 7, 1995	K953418	ELECTROCAUTERY SHROUD	GCJ	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
September 22, 1995	K954088	TELESCOPING PENEVAC	GEI	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
May 5, 1995	K944265	NEEDLE ELCTRODE	GEI	Substantially Equivalent	Unimed Surgical Products, Inc.	accessdata.fda.gov
January 13, 1989	K885200	600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE	GEI	Substantially Equivalent	Olsen Electrosurgical, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 31, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.