Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011823740

FEI Number

3011823740

Entity Name

Greatbatch Medical S. de R.L. de C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Calle 5 Norte No. 511 Ciudad Industrial, Tijuana Baja California 22444, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GREATBATCH MEDICAL (Owner Number: 9035261)

Owner / Operator Contact Address

2300 Berkshire Lane N, --, Plymouth, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CBC Charger HeartStart FRx Defibrillator HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Battery Pack Li-ion for AR-600 HeartWare Ventricular Assist System HeartStart FR3 Defibrillator PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR HeartStart OnSite Defibrillator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2014-12-23
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2021-01-04
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2014-12-23
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2014-12-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-09-28
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2014-12-23
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2021-01-04
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2014-12-23
NSA	Over-The-Counter Automated External Defibrillator	Cardiovascular	Class 3	870.5310	2021-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Mundaden Business: Director Quality and Regulatory Affairs Email: maria.mundaden@integer.net Phone: (763) 9518200

Related Public Records

Same Entity

GREATBATCH MEDICAL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007882731	Greatbatch Medical, S. de R.L. de C.V.	Tijuana Baja California, MX
3010326622	Centro de Construccion de Cardioestimuladores del Uruguay S.A.	Montevideo, UY
2183787	Greatbatch Medical	Minneapolis, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K203231	Philips North America, LLC	Switched Internal Paddles	2021-01-11
K200849	Remote Diagnostic Technologies, Ltd. A Philips Company	Tempus LS - Manual	2020-07-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.

Similar Registrations

Registration Number	Establishment Name	Location
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3016245399	NPA de Mexico S.de R.L. de C.V.	Tijuana Baja California, MX
3040335671	Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork (County), IE
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011823740. Last updated year: 2026. Please use registration number 3011823740 when referencing this establishment in official correspondence.