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Ecleris SRL: FDA-registered device maker in Villa Martelli Buenos Aires, Argentina, 3 510(k) clearances

Name: Ecleris SRL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ecleris SRL is registered with the FDA (registration 3005216736) in Villa Martelli Buenos Aires, Argentina. It lists 18 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 9, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005216736
Address: Francisco Narciso Laprida 4949/55/57, Villa Martelli Buenos Aires, Argentina, B1603ABK
Owner or operator: ECLERIS SRL (9074404)
Roles: Manufacturer, Specification developer
First device listed: June 21, 2005
Registered through: 2026
Brand names listed: EVERLUX LED100G2, Everlux, Everlux LED 100G2, HeadLux, LED Headlux, Laryngoscope, Microstar C-100, Microstar C-200 and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Camera, Television, Endoscopic, Without Audio	FWF	1	Manufacturer	accessdata.fda.gov
Camera, Television, Microsurgical, Without Audio	FWD	1	Manufacturer	accessdata.fda.gov
Colposcope (And Colpomicroscope)	HEX	2	Manufacturer	accessdata.fda.gov
Flowmeter, Calibration, Gas	BXY	1	Manufacturer	accessdata.fda.gov
Headlamp, Operating, Battery-Operated	HPP	1	Specification developer	accessdata.fda.gov
Headlight, Fiberoptic Focusing	FCT	2	Specification developer	accessdata.fda.gov
Laryngoscope, Non-Rigid	CAL	1	Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Manufacturer	accessdata.fda.gov
Laryngostroboscope	EQL	1	Manufacturer	accessdata.fda.gov
Led Light Source	NTN	2	Manufacturer, Specification developer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Specification developer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Manufacturer	accessdata.fda.gov
Microscope, Surgical	EPT	1	Manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Manufacturer	accessdata.fda.gov
Nystagmograph	GWN	2	Manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Manufacturer	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	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
June 9, 2014	K131323	ECLERIS SINUSCOPE	EOB	Substantially Equivalent	Ecleris USA	accessdata.fda.gov
April 26, 2013	K130201	NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM	GWN	Substantially Equivalent	Ototronix, LLC	accessdata.fda.gov
July 9, 2010	K100595	ECLERIS MICROSTAR COLPOSCOPE	HEX	Substantially Equivalent	Ecleris USA	accessdata.fda.gov

Compare with other makers

Updated June 9, 2014. 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.