BERND RICHTER GMBH

FDA Device Registration & Listing · Wipperfuerth North Rhine-Westphalia, DE · Registration 3004035727

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004035727
FEI Number
3004035727
Entity Name
BERND RICHTER GMBH
City/State/Country
Wipperfuerth North Rhine-Westphalia, DE
Establishment Address
Hansestrasse 4, Wipperfuerth North Rhine-Westphalia 51688, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Bernd Richter GmbH (Owner Number: 10046701)
Owner / Operator Contact Address
Hansestrasse 4, Wipperfuerth, DE-NW 51688, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ASSY, CABLE, MFC, 14 FT, R SERIES Assy, Cable, one-step, R Series CABLE, 3 LEAD ECG/ESU, R SERIES CABLE, 5 LEAD ECG, R Series, IEC ASSY, CABLE, MFC, R SERIES CABLE, 5 LEAD ECG/ESU, R SERIES, AHA 7-Lead patient cable 5-Lead patient cable Assy, cable 12 lead ECG black Cable, ECG, V-Lead black, 2.5 ft CABLE ASSY, ECG PIGTAIL, E-SERIES Cable, Multi Function DPLX SHLD, 12 ft Cable, Multi Function DPLX SHLD, 7.5 ft Cable, ECG, V-Lead black, 3.5 ft PATIENT CABLE - SINGLE CHANNEL BLACK / WHITE, PRODUCT CODE 23-0059 PATIENT CABLE 2 CHANNEL, PRODUCT CODE 23-0051 5-Lead patient cable NEMCA144 3-Lead patient cable NEMCA145 5-Lead patient cable NEMCA134 3-Lead patient cable NEMCA150 3-Lead patient cable NEMCA146 5-Lead patient cable NEMCA149 2-Lead patient cable NEMCA135 PAT CBL 10WIRE IEC BANANA JSCREW PAT CBL 10WIRE AHA BANANA JSCREW PAT CBL 10WIRE IEC SNAP JSCREW PAT CBL 10WIRE AHA SNAP JSCREW 6-lead adapter cable 10 Electrode Patient Cable Product Code 25-0021 Pinch / US 10 Electrode Patient Cable Product Code 25-0020 4mm / US 10 Electrode Patient Cable Product Code 25-0028 Pinch 10 Electrode Patient Cable Product Code 25-0026 pinch/short 10 Electrode Patient Cable, Pinch 10 Electrode Patient Cable Product Code 25-0025 4mm 5ft Trunk cable with IEC limb leads 5ft Trunk cable with AHA limb leads 8ft Trunk cable with IEC limb leads 2 LEAD ECG, PRECORDIAL LEADS (AHA) 12 LEAD ECG, PRECORDIAL LEADS (IEC) 8ft Trunk cable with AHA limb leads 7-Lead patient cable 5-Lead patient cable PAT CBL 5WIRE 2x5 RA SNAPS BI-POLAR GRAY PAT CBL H3+ 5WIRE AHA SNAP PAT CBL H3+ 5-WIRE 2X5 RA SNAPS IEC GRAY PATIENT CABLE H3+ 5-WIRE IEC SNAP GRAY PAT CBL H3+ 5WIRE SHORT AHA SNAP PAT CBL H3+ 5WIRE IEC SNAP PATIENT CABLE H3+ 5-WIRE 2-CH SNAP GRAY PAT CBL H3+ 5WIRE/2CH SNAP CABLE H3+ USB DOWNLOAD GRAY PATIENT CABLE H3+ 5-WIRE AHA SNAP GRAY PAT CBL H3+ 5-WIRE 2X5 RA SNAPS AHA GRAY 4-lead ECG Patientcable 8' with defi press stud 20kOhm IEC - 21pin connector 4-lead ECG Patientcable 5' with defi press stud 20kOhm AHA - 21pin connector 6-lead ECG Precordial cable with defi press stud 20kOhm AHA-10pin connector 5-lead ECG cable Defi press stud 20 kOhm, IEC -21 pin connector 3-lead ECG cable Defi press stud 20kOhm AHA - 21pin. connector 5-lead ECG cable Defi press stud 20 kOhm, AHA -21 pin connector 4-lead ECG Patientcable 8' with defi press stud 20kOhm AHA - 21pin connector 4-lead ECG Patientcable 5' with defi press stud 20kOhm IEC - 21pin connector 6-lead ECG Precordial cable with defi press stud 20kOhm IEC-10pin connector 3-lead ECG Precordial cable with defi press stud 20kOhm - 4pin connector 3-lead ECG cable Defi press stud 20kOhm IEC - 21pin. connector PATIENT CBL,REST, PRO,BANANA,AHA PATNT CBL, LONG, REST, PRO, BAN, IEC PATIENT CBL, STRESS, PRO, PUSH, IEC PATIENT CBL, STRESS, PRO, CLIP, AHA PATNT CBL, STRESS,LG LIMB, PRO, CLIP, AHA PATNT CBL,STRESS,LG LIMB, PRO,PUSH,IEC PATIENT CBL, REST, PRO, BANANA, IEC PATNT CBL,STRESS,LG LIMB, PRO,CLIP,IEC PATIENT CABLE, MD, BANANA, AHA PATIENT CBL,STRESS, PRO,CLIP,IEC CABLE PATIENT STRESS AHA CABLE PATIENT RESTING AHA Quik Combo Cable with IFU Quik Combo Cable 5-Lead patient cable 7-Lead patient cable Leadset 5-Lead Limb DIN, AAMI Leadset 5-Lead Chest DIN, AAMI Tempus Pro 3-lead Neonatal ECG Cable (AAMI) 6ft Tempus Pro 3-lead ECG Cable (AAMI) 6ft Tempus Pro 5-lead ECG Cable (AAMI) 8ft 3-Lead Neo ECG Modular Cable (IEC) 6ft 5-Lead ECG Cable (IEC) 8ft 5-Lead ECG Cable (IEC) 6ft 4-lead modular trunk cable (AAMI) Tempus Pro 3-lead ECG Cable (AAMI) 8ft 4-Lead ECG Modular Cable (IEC) 8ft Tempus Pro 5-lead ECG Cable (AAMI) 6ft 12-Lead ECG Cable (IEC) 6ft Tempus Pro 12-lead ECG Cable (AAMI) 8ft 6-lead ECG chest leads (AAMI) 3-Lead ECG CBL (IEC) 6ft Tempus Pro 12-lead ECG Cable (AAMI) 6ft 6-Lead ECG Limb Leads (IEC) 12-Lead ECG Cable (IEC) 8ft 3-Lead ECG Cable (IEC) 8ft

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 2017-06-09
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2017-06-09
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2017-06-09
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2017-06-09
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2017-06-09
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2017-06-09
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2017-06-09
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2019-04-03
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2017-06-09
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2017-06-09
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2017-06-09
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2017-06-09
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2024-12-18
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2017-06-09
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2017-06-09
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2024-12-18
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2017-06-09
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2017-08-15

Official Correspondent

Christopher Kott

US Agent Details

Michael Virusso Business: Amphenol Alden Products Email: mike.virusso@amphenolalden.com Phone: (781) 9531570

Related Public Records

Same Entity

Bernd Richter 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
K820986 Dart Medical Equipment EKG MONITORS, VARIOUS MODELS 1982-04-29
K910450 Medtech Industries, Inc. CARD GUARD-3000 ECG TELEPHONE ADAPTER 1991-05-07
K761318 Cambridge Instruments, Inc. 3038 OPTION B-COMPUT. TRANS. TERMINAL 1977-01-06
K972649 Reynolds Medical , Ltd. CARDIOCALL CARDIAC EVENT RECORDER 1997-12-04
K033410 Remote Diagnostic Technologies , Ltd. TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 2004-03-05

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004035727. Last updated year: 2026. Please use registration number 3004035727 when referencing this establishment in official correspondence.
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