Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010030355

FEI Number

3010030355

Entity Name

PHYSIO-CONTROL MAASTRICHT, INC.

City/State/Country

Maastricht Limburg, NL

Establishment Address

Gaetano Martinolaan 50, Maastricht Limburg 6229 GS, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Physio-Control Maastricht, Inc. (Owner Number: 10058200)

Owner / Operator Contact Address

Gaetano Martinolaan 50, Maastricht, NL-LI 6229 GS, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161768

PMA Number

N/A

All Registered Proprietary Names

LIFEPAK 12 LUCAS 2 LIFEPAK CR Plus LIFEPAK EXPRESS LIFEPAK 15 LIFEPAK 35 Monitor/Defibrillator, LIFEPAK FLEX Battery LIFEPAK 20 LIFEPAK 20E LIFEPAK 1000 LIFEPAK 35 LIFEPAK 500 LUCAS 3 LIFEPAK CR2 LUCAS ANTI SLIP, SLIM BACK PLATE LUCAS 3 LUCAS BATTERY, DARK GRAY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-07-26
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2018-07-26
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-07-26
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-07-26
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-07-26
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2018-07-26
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-10-13
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2024-12-04

Official Correspondent

Robbert Vogels

US Agent Details

Meriam Gabera Email: meriam.gabera@stryker.com Phone: (732) 8248230

Related Public Records

Same Entity

Physio-Control Maastricht, Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Similar Registrations

Registration Number	Establishment Name	Location
2112020	ZOLL Medical Corporation	DEERFIELD, WI, US
3029871637	ZOLL International Holding B.V.	Elst Gelderland, NL
3015876	PHYSIO-CONTROL, INC.	Redmond, WA, US
3017422354	EMI (DONGGUAN) ASIA LIMITED	Dongguan City Guangdong, CN
3011823740	Greatbatch Medical S. de R.L. de C.V.	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010030355. Last updated year: 2026. Please use registration number 3010030355 when referencing this establishment in official correspondence.