FDA Registration
Active
🇩🇪 Germany
BERND RICHTER GMBH
Reg #: 3004035727
·
FEI: 3004035727
·
Expires 2026
Products
14
Proprietary Names
127
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- BERND RICHTER GMBH
- Registration Number
- 3004035727
- FEI Number
- 3004035727
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hansestrasse 4
- City
- Wipperfuerth North Rhine-Westphalia
- Country
- DE
Owner / Operator
- Firm Name
- Bernd Richter GmbH
- Operator Number
- 10046701
- Address
- Hansestrasse 4
- City
- Wipperfuerth
- State
- North Rhine-Westphalia
- Postal Code
- 51688
- Country
- DE
- Correspondent
- Christopher Kott
US Agent
- Business Name
- Amphenol Alden Products
- Contact Name
- Michael Virusso
- Address
- 800 Technology Center Dr
- City
- Stoughton
- State
- MA
- ZIP
- 02072
- Country
- US
- [email protected]
- Phone
- 781 9531570
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2017-06-09 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2017-06-09 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2017-06-09 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2017-06-09 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2017-06-09 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2017-06-09 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2024-12-18 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2017-06-09 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2017-08-15 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2017-06-09 |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | Class 2 | Hematology | No | 2017-06-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-06-09 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-01-05 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-01-05 |
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
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
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
Patient Cable, Pinch type, IQstress
Patient Cable, Standard, for IQecg with Lead Management
Patient Cable, Standard, IQecg
ECG CABLE RDS TRUNK/YOKE 13/14 WIRE
PATIENT CABLE, RDS, 10 Wire, Banana, IEC
RPLCMNT LEAD SET RDS 10 WIRE CLIPS IEC
ECG CABLE RDS 10 WIRE BANANA AHA
ECG CABLE RDS 13 WIRE BANANA AHA
RPLCMNT LEAD SET RDS 10 WIRE BANANA AHA
ECG CABLE RDS 10 WIRE CLIPS IEC
REPLACEMENT RDS LIMBS AHA BANANA
REPLACEMENT RDS C1-C3 IEC BANANA
RPLCMNT LEAD SET RDS 10 WIRE BANANA IEC
PAT CBL 10WIRE AHA BANANA WA JSCREW
Stress ECG Trunk Cable, Replaceable, IEC/AHA
REPLACEMENT RDS V1-V3 AHA BANANA
RPLCMNT LEAD SET RDS 10 WIRE CLIPS AHA
REPLACEMENT RDS C4-C6 IEC BANANA
REPLACEMENT RDS V3R, V4R, V7 BANANA AHA
ECG CABLE RDS 13 WIRE BANANA IEC
REPLACEMENT RDS V4-V6 AHA BANANA
CABLE PATIENT STRESS AHA CareCenter MD
REPLACEMENT RDS LIMBS IEC BANANA
CABLE-EXTERNAL POWER, RIGHT ANGLE
CABLE-EXTERNAL POWER, EXTENSION
Cable Therapy, Quik Combo
PATIENT CABLE ATRIA 8x00 10-LEAD IEC
PATIENT CABLE ATRIA 8x00 10-LEAD AHA
CABLE, LEADWIRES, ECG, R/L/F
CABLE, LEADWIRES, ECG, RA/LA/LL
CABLE, EXTERNAL ECG CONNECTOR, 7-PIN TO 1/4" PLUG
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)