| EMDDB code |
21182
|
| Basic UDI-DI |
764018686CONTROLUNIT00C6
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IIa
|
| Appliance |
-
|
| Device name (in Estonian) |
GalvoSurge juhtseade GS 1000
|
| Device name (in English) |
GalvoSurge Control Unit GS 1000
|
| Intended use (is Estonian) |
GalvoSurge elektrit juhtiv puhastussüsteem on mõeldud patsiendile implanteeritud ja osseo-integreeritud implantaadilt biokile eemaldamiseks. Seda saab kasutada ülemises või alumises lõualuus.
|
| Intended use (in English) |
The GalvoSurge Dental Implant Cleaning System is used to remove biofilm from already implanted, osseo-integrated, electrically conductive dental implants on the patient. It can be used in the upper or the lower jaw.
|
| Type/model/article number |
GVS1002
|
| Notified body |
0123
|
| Manufacturer |
GalvoSurge Dental AG
|
| Authorised representative |
etkon GmbHBlue Broccoli GmbH (Kehtis kuni 10.11.2025)
|
| In register from |
10/24/2024
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
