FDA Registration
Active
🇩🇪 Germany
LivaNova Deutschland GmbH
Reg #: 9611109
·
FEI: 3002808267
·
Expires 2026
Products
11
Proprietary Names
33
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- LivaNova Deutschland GmbH
- Registration Number
- 9611109
- FEI Number
- 3002808267
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LINDBERGH STRASSE 25
- City
- MUNCHEN Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K220635
Owner / Operator
- Firm Name
- LivaNova Deutschland GmbH
- Operator Number
- 8010598
- Address
- Lindberghstrasse 25
- City
- Munich
- State
- Bavaria
- Postal Code
- 80939
- Country
- DE
- Correspondent
- Julie Leslie
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Controller, Temperature, Cardiopulmonary Bypass | DWC | Class 2 | Cardiovascular | No | 2025-11-21 |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2023-03-13 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2013-01-10 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2011-11-08 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2022-02-16 |
| Detector, Bubble, Cardiopulmonary Bypass | KRL | Class 2 | Cardiovascular | No | 2011-01-25 |
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | Class 2 | Cardiovascular | No | 2021-04-14 |
| Gas Control Unit, Cardiopulmonary Bypass | DTX | Class 2 | Cardiovascular | No | 2010-12-30 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2007-12-05 |
| NSX | No | 2010-11-02 | |||
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2009-05-04 |
Proprietary Names
Heater-Cooler System 3T
Essenz HLM
XVAC
Stockert Centrifugal Pump Console
Sorin Centrifugal Pump 5 (CP5)
ESSENZ Patient Monitor
Stöckert Air Purge Control (APC) System
B-Capta
S3 Roller Pump and Console
Sorin C5 System with EVO and Mast Pumps
Stöckert Gas Blenders (2L, 5L, and 10L)
Essenz ILBM
XTRA Autotransfusion System
Sorin C5 System
Stockert S5 System
IDDD S3/SC
Sorin CONNECT: Data Management System
Connect Manager: server application to store, manage and display data from DMS recorder in the hospital environment
Connect Reorder: online perfusion assistant inside OR embedded into a medical PC
Stockert Centrifugal Pump (SCP)
Stöckert Data Management System
Sorin DataPad II
Sorin B-Care5 for the Stockert S5
Stöckert EVO
Sorin CONNECT
Sorin B-Care5
STOCKERT HEATER COOLER SYSTEM 3T
Stöckert S5 System Gas Blender
Stöckert SCP Plus
Stöckert Air Purge Control System
AC Outlet with Isolation Transformer for S5
AC Outlet with Isolation Transformer for C5
Venous Line Clamp
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device