Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003542872

FEI Number

3003542872

Entity Name

NPA de México S. de R.L. de C.V.

City/State/Country

TIJUANA Baja California, MX

Establishment Address

Sor Juana Ines de la Cruz # 20150 Interior 5, Cd. Industrial, TIJUANA Baja California 22444, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jabil Inc. (Owner Number: 9074019)

Owner / Operator Contact Address

10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nordlys Nordlys Mini Picoway Laser System Cutera AviClear Laser System Mixer Profound Matrix 3M Ranger Blood/Fluid Warming Standard Flow Set GentleLase Pro-U GentleMax Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2013-12-22
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2014-05-15
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2014-05-15
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2018-03-23
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2020-12-18
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2019-12-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-12-19
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2017-05-01
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-10-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-01-21
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-08-04
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-01-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-11-15
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2014-08-20
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-08-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-03-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-11-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-05-12
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2015-02-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-08-04
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-03-24
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2026-05-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-03-10
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2021-01-18
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2019-06-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-03-24
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-03-02
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2025-06-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-07-02
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-03-24
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2022-02-09
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-11-08
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2015-03-03
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2015-02-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-21
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2017-10-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-10-16
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2026-03-30
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2015-02-25
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2025-02-21
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2013-08-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-06-12
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2019-06-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

Lex Pearce Business: JABIL - NYPRO HEALTHCARE DIVISION Email: lex_pearce@jabil.com Phone: (505) 2030277

Related Public Records

Same Entity

Jabil Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3011246727	Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3003512059	NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, DO
3004730544	NYPRO DR, LLC (Building 52)	Haina San Cristobal, DO
1424235	Nypro Inc. (Chicago)	GURNEE, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082762	Aardvark Medical	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	2008-11-12
K192521	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System	2019-12-06
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003542872. Last updated year: 2026. Please use registration number 3003542872 when referencing this establishment in official correspondence.