Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020045

FEI Number

6736

Entity Name

LEONHARD LANG GMBH

City/State/Country

INNSBRUCK Tirol, AT

Establishment Address

ARCHENWEG 56, INNSBRUCK Tirol A-6020, AT

Establishment Type(s)

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

Owner / Operator

LEONHARD LANG GMBH (Owner Number: 8020045)

Owner / Operator Contact Address

ARCHENWEG 56, --, INNSBRUCK, AT-NOTA A-6020, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063161

PMA Number

N/A

All Registered Proprietary Names

S&W ECG Electrodes Skintact ECG Electrodes others Skintact ECG Electrodes S&W ECG Electrodes Skintact Skintact ECG Electrodes and accessories S&W Healthcare Skintact Skintact ECG Electrodes S&W ECG Electrodes others Skintact ESU Dispersive Electrodes S&W ESU Dispersive Electrodes others

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2015-03-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2015-03-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2014-07-25
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2015-03-11
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2019-07-19
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2017-04-12
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2007-12-07
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2007-12-05
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2017-04-12
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2017-04-12
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2009-10-16
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2017-04-12
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2023-11-13
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2009-10-16
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2007-12-07
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-06-25
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2023-01-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-01-30

Official Correspondent

BURRHUS LANG

US Agent Details

ELAINE DUNCAN, MS.ME., RAC, AIMBE Business: PALADIN MEDICAL, INC. Email: DUNCAN@PALADINMEDICAL.COM Phone: (715) 5496035

Related Public Records

Same Entity

LEONHARD LANG GMBH

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
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-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020045. Last updated year: 2026. Please use registration number 8020045 when referencing this establishment in official correspondence.