LivaNova Deutschland GmbH
DE-MF-000014243 · Germany · München
LivaNova Deutschland GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 4 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: 75220, 75306, Heater Cooler System Stockert 3T, Perfusion data management system.
Among these devices, 5 are declared active.
Devices declared under this manufacturer
- Essenz Patient Monitor
- Heater Cooler System Stockert 3T
- Perfusion System Monitor
- XTRA
- XVAC
Catalogue references include 16-02-80, 24-30-00, 75220, 75306, 96-415-140.
European nomenclature codes declared: Z120104, Z12050292, Z12050201, Z12050282.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LivaNova Deutschland GmbH (DE) · FDA 9611109 |
| Devices in EUDAMED | 5 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 40.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LIVANOVA DEUTSCHLAND GMBH |
What it holds in Canada
| Licences on record | 17 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 13 |
| First licensed | 2000-05-25 |
Licence types: System (9), Device Group (6), Single Device (1), Device Group Family (1).
Licensed under: TEMPERATURE PROBE ASSEMBLY, STOCKERT CENTRIFUGAL PUMP, STOCKERT SCPC MODULAR CENTRIFUGAL PUMP CONSOLE, STOCKERT HEATER COOLER SYSTEM 3T, STOCKERT S5 HEART LUNG MACHINE SYSTEM, STOCKERT SCP PLUS.
North American profile: Both markets. LivaNova Deutschland GmbH is registered in both the United States and Canada.