Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002997683

FEI Number

3002997683

Entity Name

PROFILATEX, S.A. DE C.V.

City/State/Country

MEXICO, MX

Establishment Address

FEBRERO DE 1917 NO. 4,, COL. CIPRESES, CHALCO, MEXICO 56600, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PROFILATEX, S.A. DE C.V. (Owner Number: 10026043)

Owner / Operator Contact Address

FEBRERO DE 1917 NO. 4,, COL. CIPRESES, CHALCO, MEXICO, MX-MEX 56600, 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
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2014-05-09

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants Inc Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

PROFILATEX, 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 3002997683. Last updated year: 2026. Please use registration number 3002997683 when referencing this establishment in official correspondence.