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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 13801
Basic UDI-DI
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class IIb
Appliance -
Device name (in Estonian) TECNIS® üheosaline intraokulaarlääts
Device name (in English) The TECNIS® 1-Piece IOL
Intended use (is Estonian) TECNIS® üheosalised läätsed on mõeldud afaakia korrektsiooniks täiskasvanutel, kellel on katarakti ekstrakapsulaarsel ekstraktsioonil eemaldatud kataraktne lääts.
Intended use (in English) TECNIS® 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, ZCB00, TECNIS 1-PIECE IOLS (MULTILINGUAL)
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
Documents related to medical device model
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