Stockert GmbH
DE-MF-000006981 · Germany · Freiburg
Stockert GmbH is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 35 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: Cable Stimuplex, G4 Cables, G4 Cardio, G4 Foot Pedal, G4 Pump.
Among these devices, 1 are declared sterile, 4 active.
Devices declared under this manufacturer
- Connection Cable SMARTABLATE™ RF Generator to SMARTABLATE™ Irrigation
- Connection Cable SMARTABLATE™ RF Generator to SMARTABLATE™ Irrigation
- Connection Cable SMARTABLATE™ RF Generator to SMARTABLATE™ Remote Cont
- Electrode Cable for Stimuplex® HNS 11/12
- INTELLAGEN™ Foot Pedal
- INTELLAGEN™ Foot Pedal Extension Cable (7m)
- INTELLAGEN™ Irrigation Pump
- INTELLAGEN™ Irrigation Pump Connection Cable (1m)
- INTELLAGEN™ Irrigation Pump Connection Cable (3m)
- INTELLAGEN™ RF Generator
- INTELLAGEN™ Remote Control
- INTELLAGEN™ Remote Control Connection Cable (10m)
Showing 12 of 37 declared devices.
Catalogue references include 19960, 19980, 20000, 20072, 20084, 4892070.
European nomenclature codes declared: Z12059011, N010180, N010103.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STOCKERT GMBH (DE) · FDA 3015537323 |
| Devices in EUDAMED | 37 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 37 |
|---|---|
| Found in the U.S. device database | 32 |
| Share | 86.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STOCKERT GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 3 |
| First licensed | 2003-06-09 |
Licence types: System (4).
Licensed under: INTELLAGEN CARDIAC ABLATION SYSTEM, STOCKERT EP SHUTTLE RADIOFREQUENCY GENERATOR S, SMARTABLATE SYSTEM IRRIGATION PUMP, SMARTABLATE SYSTEM.
North American profile: Both markets. Stockert GmbH is registered in both the United States and Canada.