Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005440755

FEI Number

3005440755

Entity Name

Laboratorios PISA S.A. de C.V.

City/State/Country

GUADALAJARA Jalisco, MX

Establishment Address

CALLE 7, N0. 1308 ZONA INDUSTRIAL, GUADALAJARA Jalisco C.P. 44940, MX

Establishment Type(s)

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

Owner / Operator

Laboratorios PiSA S.A. de C.V (Owner Number: 9079024)

Owner / Operator Contact Address

Av. Espana No 1840, Col. Moderna, Guadalajara, MX-JAL 44190, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STERILE WATER & SALINE IN PLASTIC BTL.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-12-15
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2014-02-05
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2010-07-19
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-07-19

Official Correspondent

No official correspondent registered.

US Agent Details

Raza Mohammed Business: Pisa Manufacturing Inc Email: raza.mohammed@pisamfg.com Phone: (518) 9925944

Related Public Records

Same Entity

Laboratorios PiSA 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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005440755. Last updated year: 2026. Please use registration number 3005440755 when referencing this establishment in official correspondence.