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Terviseamet

Medical device

MSA code 16976
UDI code
Seadme klass Meditsiiniseade
Risk class IIa
Appliance -
Device name (in Estonian) Bausch + Lomb ULTRA® ONE DAY (kalifilcon A) kontaktläätsed
Device name (in English) Bausch + Lomb ULTRA® ONE DAY (kalifilcon A) Contact Lenses
Intended use (is Estonian) Bausch + Lomb ühepäevased pehmed kontaktläätsed on näidustatud päevaseks kandmiseks refraktiivse ametroopia (müoopia ja hüperoopia) korrigeerimise ning sfäärilise aberratsiooni vähendamise eesmärgil afaakiliste ja/või mitteafaakiliste muidu tervete silmadega inimestele, kelle astigmatism ei ületa 2,00 dioptriat ning ei mõjuta nägemisteravust. Saadaval on läätsed sfäärilise tugevusega dioptrites +20,00 D kuni -20,00 D.
Intended use (in English) The Bausch + Lomb daily disposable soft contact lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) and reduction of spherical aberration in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
Type/model/article number KAPBSDD
Additional information There are more than 1 packaging artwork for Ultra One Day daily disposable lenses as at the manufacturing site in Waterford there are multiple machines that are used to carton lenses and the carton dieline may need to be different depending on the cartoner. Therefore several artworks exist.
Notified body 0050
Manufacturer Bausch & Lomb Incorporated
Authorized spokesman Bausch & Lomb Incorporated Ireland
In register from 10/15/2021
Status Active
EHK soodustus EHK soodustus puudub
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