SICAT GmbH & Co. KG
DE-MF-000005604 · Germany · Bonn
SICAT GmbH & Co. KG 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 | 5 |
|---|
Most frequent device types declared: V1.0.
Among these devices, 4 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- SICAT AIR V2.0.40
- SICAT Bite Plate
- SICAT ENDO V2.0.40
- SICAT FUNCTION V2.0.40
- SICAT IMPLANT V2.0.40
Catalogue references include 10251701, 10260501, 10271501, 10280501, 10300.
European nomenclature codes declared: Z110603, Q010399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SICAT GMBH & CO. KG (DE) · FDA 3006098230 |
| Devices in EUDAMED | 5 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SICAT GMBH & CO. KG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2009-01-19 |
Licence types: Device Family (3), Single Device (1).
Licensed under: RADIOLOGICAL VISUALIZATION SOFTWARE FOR DIAGNO, RADIOLOGICAL VISUALIZATION SOFTWARE FOR DIAGNO, SICAT ENDO, SICAT AIR.
North American profile: Both markets. SICAT GmbH & Co. KG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1703016-1 | issued | 2026-06-25 |
HZ 1703016-1 | reissued | 2031-06-25 |