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Terviseamet

Medical device

MSA code 13811
UDI code
Seadme klass Meditsiiniseade
Risk class IIb
Appliance -
Device name (in Estonian) OcuCoat 2 ml
Device name (in English) OcuCoat 2 ml
Intended use (is Estonian) OcuCoati kasutamine on näidustatud oftalmilise kirurgia abivahendina anterioorse segmendi kirurgiaprotseduuride läbiviimisel, näiteks katarakti ekstraktsioonil ja silmasisese läätse implanteerimisel.
Intended use (in English) OcuCoat is indicated for use as an ophthalmic surgical aid in anterior segment surgical procedures, including cataract extraction and intraocular lens implantation.
Type/model/article number OcuCoat 2 ml, ref. CC100SL
Notified body 0197
Manufacturer Bausch & Lomb Incorporated
Authorized spokesman Baush & Lomb GmbH
In register from 08/14/2019
Status Active
EHK soodustus EHK soodustus puudub
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