Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710643

FEI Number

3002710954

Entity Name

PLASTICOS Y MATERIAS PRIMAS, S.A. DE C.V.

City/State/Country

GUADALAJARA Jalisco, MX

Establishment Address

3609-2 JUAN DE LA BARRERA, GUADALAJARA Jalisco 44490, MX

Establishment Type(s)

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

Owner / Operator

PLASTICOS Y MATERIAS PRIMAS, S.A. DE C.V. (Owner Number: 9047982)

Owner / Operator Contact Address

3609-2 JUAN DE LA BARRERA, --, GUADALAJARA, JALISCO, MX-NOTA 44470, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EM2400 Tube Sets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2009-12-16
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2009-12-16

Official Correspondent

CELIA HERNANDEZ MELENDEZ

US Agent Details

Raza Mohammed Business: Pisa Biopharm Inc Email: Raza.mohammed@pisa-biopharm.com Phone: (518) 9925044

Related Public Records

Same Entity

PLASTICOS Y MATERIAS PRIMAS, 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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Similar Registrations

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3006153342	Omnicell S.R.L.	TRIESTE, IT
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710643. Last updated year: 2026. Please use registration number 9710643 when referencing this establishment in official correspondence.