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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 15356
Basic UDI-DI
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class IIa
Appliance -
Device name (in Estonian) Tuloc Premium
Device name (in English) Tuloc Premium
Intended use (is Estonian) Toode on ette nähtud mittepalpeeritavate rinnanäärme kahjustuste operatsioonieelseks markeerimiseks, et hõlbustada kirurgil kahjustuse asukoha leidmist operatsiooni ajal.
Intended use (in English) The product is intended as a preoperative marker of non-palpable suspected breast lesions to facilitate the intraoperative localization of the findings by the surgeon.
Type/model/article number 271880, 271881, 271883
Notified body 0482
Manufacturer Somatex Medical Technologies GmbH
In register from 07/31/2020
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
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