FDA Registration
Active
🇩🇪 Germany
Lumax
Reg #: 9610139
·
FEI: 3002806500
·
Expires 2025
Products
7
Proprietary Names
19
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- BIOTRONIK SE & CO. KG
- Registration Number
- 9610139
- FEI Number
- 3002806500
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- WOERMANNKEHRE 1
- City
- BERLIN
- Country
- DE
Regulatory Submissions
- PMA Number
- P050023
Owner / Operator
- Firm Name
- BIOTRONIK SE & CO. KG
- Operator Number
- 9018331
- Address
- 6024 Jean Road
- City
- Lake Oswego
- State
- OR
- Postal Code
- 97035
- Country
- US
US Agent
- Business Name
- BIOTRONIK, Inc.
- Contact Name
- Jon Brumbaugh
- Address
- 6024 Jean Rd
- City
- Lake Grove
- State
- OR
- ZIP
- 97035
- Country
- US
- [email protected]
- Phone
- 503 9707014
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2008-12-30 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2008-12-30 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2008-12-30 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2008-12-30 |
| Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | OJX | Class 3 | Unknown | No | 2008-12-30 |
| Defibrillator, Implantable, Dual-Chamber | MRM | Class 3 | Unknown | No | 2008-12-30 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2008-12-30 |
Proprietary Names
Lumax
Ilesto
Iforia
Itrevia
Iperia
PSW 1503.U
Inventra
PSW 1502.U
PSW 1506.U
PSW 1507.U
Intica
BS IS4
Ilivia
CardioMessenger Smart 4G
Acticor family
ICS 3000
Renamic
CardioMessenger
Home Monitoring
Establishment Types
Manufacture Medical Device