| EMDDB code |
22903
|
| Basic UDI-DI |
08406631CardioCelUW
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
P07020101 Pericardium vascular patches
|
| Risk class |
III
|
| Appliance |
-
|
| Device name (in Estonian) |
Bioloogiline tugiplaaster CardioCel
|
| Device name (in English) |
CardioCel Bioscaffold Patch
|
| Intended use (is Estonian) |
Plaaster CardioCel on ette nähtud kasutamiseks plaastrina südame- ja veresoonedefektide korral. Plaastrimaterjal on püsiimplantaat, mida kasutatakse kahjustatud arterite või südamekoe parandamiseks.
|
| Intended use (in English) |
The CardioCel patch is intended for use as a patch in cardiac and vascular defects. The patch material is a permanent implant used to repair damaged arteries or cardiac tissue.
|
| Type/model/article number |
EC0614
|
| Notified body |
2797
|
| Manufacturer |
LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803
|
| Authorised representative |
LeMaitre Vascular GmbH
|
| In register from |
12/02/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
