FDA Registration
Active
🇩🇪 Germany
Cable, ECG, V-Lead black, 3.5 ft
Reg #: 3004035727
·
FEI: 3004035727
·
Expires 2025
Products
1
Proprietary Names
6
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
- K140502
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 |
|---|---|---|---|---|---|
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2017-06-09 |
Proprietary Names
Cable, ECG, V-Lead black, 3.5 ft
CABLE ASSY, ECG PIGTAIL, E-SERIES
Cable, ECG, V-Lead black, 2.5 ft
Assy, cable 12 lead ECG black
Cable, Multi Function DPLX SHLD, 7.5 ft
Cable, Multi Function DPLX SHLD, 12 ft
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)