Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007502289

FEI Number

3007502289

Entity Name

Laboratorios PiSA, S. A. de C.V.

City/State/Country

Tlajomulco de Zuniga Jalisco, MX

Establishment Address

Carretera San Isidro Mazatepec No. 7000, Santa Cruz de las Flores, Tlajomulco de Zuniga Jalisco C.P. 45640, MX

Establishment Type(s)

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

Owner / Operator

Laboratorios PiSA S.A. de C.V. (Owner Number: 10028650)

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 OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 Sterile Water for Inhalation in 1L Flexoval ® bottles. BIASURGE Advanced Surgical Solution Bactisure Wound Lavage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2013-01-07
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2016-11-28
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2024-03-25
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2024-03-25
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-01-05
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2010-07-19
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-11-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-11-01
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-07-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2011-01-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2013-01-07
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-06-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-06-21

Official Correspondent

No official correspondent registered.

US Agent Details

Raza Mohammed Business: Pisa Manufacturing Inc Email: raza.mohammed@pisamfg.com Phone: (518) 9925044

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
K033458	Becton, Dickinson & CO	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST	2004-05-28
K112000	bioMerieux, Inc.	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007502289. Last updated year: 2026. Please use registration number 3007502289 when referencing this establishment in official correspondence.