Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014674312

FEI Number

3014674312

Entity Name

POLIURETANOS, S.A. DE C.V.

City/State/Country

Toluca Mexico, MX

Establishment Address

Alfredo Nobel s/n, Zona Industrial, Toluca Mexico 50010, MX

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Poliuretanos, S.A. de C.V. (Owner Number: 10058114)

Owner / Operator Contact Address

Alfredo Nobel s/n, Zona Industrial, Toluca, MX-MEX 50010, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hybrid foam Gel Cushion Bariatric Mattresses ShearCare Mattresses DynamicElite Mattresses 15019 Mattress Stretch Pad Mattresses Gravity 6,7,8,9 Mattresses Bradshaw Junior Contour Mattress Dermaprox Pads - Patient positioning Foam

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2018-07-11
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2018-07-11
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2025-09-24
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2018-07-11

Official Correspondent

Juan Pablo Dosal

US Agent Details

Susan Scott Business: Drive Medical Email: Licensing@drivemedical.com Phone: (516) 9984600

Related Public Records

Same Entity

Poliuretanos, 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 3014674312. Last updated year: 2026. Please use registration number 3014674312 when referencing this establishment in official correspondence.