MSA code |
13800
|
Basic UDI-DI |
|
Seadme klass |
Meditsiiniseade
|
Medical Device Nomenclature |
|
Risk class |
IIb
|
Appliance |
-
|
Device name (in Estonian) |
SENSARi üheosaline intraokulaarlääts
|
Device name (in English) |
The SENSAR 1-Piece IOL
|
Intended use (is Estonian) |
SENSARi üheosalised läätsed on mõeldud afaakia korrektsiooniks täiskasvanutel, kellel on katarakti ekstrakapsulaarsel ekstraktsioonil eemaldatud kataraktne lääts.
|
Intended use (in English) |
SENSAR 1-piece lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular
cataract extraction.
|
Type/model/article number |
DFU, SENSAR 1-PIECE IOL
|
Notified body |
0344
|
Manufacturer |
Johnson & Johnson Surgical Vison, Inc.
|
Authorised representative |
AMO Groningen BV
|
In register from |
07/31/2019
|
Entry status |
Active
|
Reimbursed by EHIF |
Tervisekassa soodustus puudub
|