Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000256895

FEI Number

3000256895

Entity Name

LABORATORIOS LE ROY, S.A. DE C.V.

City/State/Country

YECAPIXTLA Morelos, MX

Establishment Address

CARRETERA YECAPLIXTLA -AGUA HEDIONDA KM. 2.5 S/N, YECAPIXTLA Morelos 62820, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LABORATORIOS LE ROY S.A. DE C.V. (Owner Number: 9048904)

Owner / Operator Contact Address

AV. COYOACAN N 1622 TORRE UNO, PLANTA BAJA, COL. SANTA CRUZ ATOYAC, ALCALDIA BENITO JUAREZ, MEXICO CITY, MX-NOTA 03310, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-09-24
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2025-03-27
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-03-27
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2007-12-03
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2001-12-19

Official Correspondent

HERNANDO GARCIA

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

LABORATORIOS LE ROY S.A. DE C.V.

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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000256895. Last updated year: 2026. Please use registration number 3000256895 when referencing this establishment in official correspondence.