Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005216736

FEI Number

3005216736

Entity Name

ECLERIS SRL

City/State/Country

Villa Martelli Buenos Aires, AR

Establishment Address

Francisco Narciso Laprida 4949/55/57, Villa Martelli Buenos Aires B1603ABK, AR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ECLERIS SRL (Owner Number: 9074404)

Owner / Operator Contact Address

Francisco N. Laprida 4955, Villa Martelli, Buenos Aires, AR-NOTA B1603ABK, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130201

PMA Number

N/A

All Registered Proprietary Names

Microstar C-100 Microstar C-200 Microstar OM-100 Microstar OM-200 Microstar C-200 HeadLux LED Headlux Laryngoscope PortaLED EVERLUX LED100G2 Everlux Minivac Laryngoscope PortaLED020 PortaLED Procam HD II Procam HD Basic Otoscope StroboLED R-Flowmeter VNG 3D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2010-08-02
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2005-06-21
FCT	Headlight, Fiberoptic Focusing	Ophthalmic	Class 2	886.4335	2021-12-09
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2010-12-21
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2006-09-05
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2007-02-06
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2007-06-06
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2021-11-01
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2021-11-01
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2007-02-06
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2021-11-01
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2005-06-21
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2024-01-08
GWN	Nystagmograph	Neurology	Class 2	882.1460	2024-04-22

Official Correspondent

No official correspondent registered.

US Agent Details

Henry Sand Email: hsand@ecleris.com Phone: (786) 4837490

Related Public Records

Same Entity

ECLERIS SRL

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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K010059	Western Systems Research, Inc.	ENGPLUS	2001-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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3008393409	XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD	Xuzhou Jiangsu, CN
3003969012	Alltion (Guangxi) Instrument Co., Ltd.	Wuzhou City Guangxi, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005216736. Last updated year: 2026. Please use registration number 3005216736 when referencing this establishment in official correspondence.