FDA Registration
Active
🇩🇪 Germany
5ft Trunk cable with AHA limb leads
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
- K102972
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 |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2017-06-09 |
Proprietary Names
5ft Trunk cable with AHA limb leads
5ft Trunk cable with IEC limb leads
12 LEAD ECG, PRECORDIAL LEADS (IEC)
8ft Trunk cable with AHA limb leads
8ft Trunk cable with IEC limb leads
2 LEAD ECG, PRECORDIAL LEADS (AHA)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)