FDA Registration
Active
🇩🇪 Germany
RPLCMNT LEAD SET RDS 10 WIRE CLIPS IEC
Reg #: 3004035727
·
FEI: 3004035727
·
Expires 2025
Products
1
Proprietary Names
20
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
- K092663
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 |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2017-06-09 |
Proprietary Names
RPLCMNT LEAD SET RDS 10 WIRE CLIPS IEC
REPLACEMENT RDS C1-C3 IEC BANANA
ECG CABLE RDS 13 WIRE BANANA IEC
ECG CABLE RDS 10 WIRE CLIPS IEC
REPLACEMENT RDS LIMBS IEC BANANA
RPLCMNT LEAD SET RDS 10 WIRE BANANA IEC
ECG CABLE RDS TRUNK/YOKE 13/14 WIRE
PAT CBL 10WIRE AHA BANANA WA JSCREW
RPLCMNT LEAD SET RDS 10 WIRE CLIPS AHA
RPLCMNT LEAD SET RDS 10 WIRE BANANA AHA
REPLACEMENT RDS LIMBS AHA BANANA
REPLACEMENT RDS V3R, V4R, V7 BANANA AHA
REPLACEMENT RDS V4-V6 AHA BANANA
REPLACEMENT RDS V1-V3 AHA BANANA
Stress ECG Trunk Cable, Replaceable, IEC/AHA
ECG CABLE RDS 13 WIRE BANANA AHA
CABLE PATIENT STRESS AHA CareCenter MD
ECG CABLE RDS 10 WIRE BANANA AHA
PATIENT CABLE, RDS, 10 Wire, Banana, IEC
REPLACEMENT RDS C4-C6 IEC BANANA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)