FDA Registration
Active
🇩🇪 Germany
3-lead ECG cable Defi press stud 20kOhm AHA - 21pin. connector
Reg #: 3004035727
·
FEI: 3004035727
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BERND RICHTER GMBH
- Registration Number
- 3004035727
- FEI Number
- 3004035727
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hansestrasse 4
- City
- Wipperfuerth North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K240377
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
- Bernd Richter USA, Inc.
- Contact Name
- David Krohn
- Address
- 2097 Iglehart Ave.
- City
- Saint Paul
- State
- MN
- ZIP
- 55104
- Country
- US
- [email protected]
- Phone
- 651 4420278
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2024-12-18 |
Proprietary Names
3-lead ECG cable Defi press stud 20kOhm AHA - 21pin. connector
3-lead ECG cable Defi press stud 20kOhm IEC - 21pin. connector
5-lead ECG cable Defi press stud 20 kOhm, AHA -21 pin connector
5-lead ECG cable Defi press stud 20 kOhm, IEC -21 pin connector
4-lead ECG Patientcable 8' with defi press stud 20kOhm IEC - 21pin connector
4-lead ECG Patientcable 8' with defi press stud 20kOhm AHA - 21pin connector
3-lead ECG Precordial cable with defi press stud 20kOhm - 4pin connector
6-lead ECG Precordial cable with defi press stud 20kOhm AHA-10pin connector
6-lead ECG Precordial cable with defi press stud 20kOhm IEC-10pin connector
4-lead ECG Patientcable 5' with defi press stud 20kOhm IEC - 21pin connector
4-lead ECG Patientcable 5' with defi press stud 20kOhm AHA - 21pin connector
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)