Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030674

FEI Number

1000162577

Entity Name

ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.

City/State/Country

Tlalnepantla, Estado de Mexico, MX

Establishment Address

Guillermo Barroso No. 11-A, Fraccionamiento Industrial Las Armas, Tlalnepantla, Estado de Mexico 54080, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V. (Owner Number: 10029578)

Owner / Operator Contact Address

Guillermo Barroso No. 11-A, Fraccionamiento Industrial Las Armas, Tlalnepantla, Estado de Mexico, MX-MEX 54080, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wrap, sterilization

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2009-06-01

Official Correspondent

Nicole Pla Mobarak

US Agent Details

Celena Frazier Business: Sterimed Inc. Email: quality@sterimed.us Phone: (843) 3888080

Related Public Records

Same Entity

ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030674. Last updated year: 2026. Please use registration number 8030674 when referencing this establishment in official correspondence.