Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617248

FEI Number

3005435924

Entity Name

OPTOMIC ESPANA, S.A.

City/State/Country

COLMENAR VIEJO Madrid (Province), ES

Establishment Address

MADRONO 4F, POL. IND. LA MINA, COLMENAR VIEJO Madrid (Province) 28770, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OPTOMIC ESPANA, S.A. (Owner Number: 9037801)

Owner / Operator Contact Address

MADRONO 4, POL IND LA MINA, COLMENAR VIEJO, ES-M 28770, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OPTOMIC FIBEROPTIC LIGHT SOURCES OPTOMIC LARYNGOSCOPES OPTOMIC OTOSCOPES STROBOLUX III STROBOLUX II OPTOMIC ENDOSCOPIC CAMERAS OPTOMIC EXAMINATION AND SURGICAL MICROSCOPES EXAMINATION STEREO MICROS EXAMINATION STEREO MICROSCOPES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	1999-04-27
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2013-02-11
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2013-02-11
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2003-09-10
FWD	Camera, Television, Microsurgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	1999-04-27
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	1999-04-27
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	1999-04-27

Official Correspondent

Pablo D RIAL HUTT

US Agent Details

Nicolas Fontanillas Business: Spain-US Chamber of Commerce Email: fda@spainchamber.org Phone: (305) 3585988

Related Public Records

Same Entity

OPTOMIC ESPANA, S.A.

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

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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3009255580	SWENGG CO	Sialkot Punjab, PK
3010331645	Arthrex, Inc.	Ave Maria, FL, US
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617248. Last updated year: 2026. Please use registration number 9617248 when referencing this establishment in official correspondence.