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MSA code |
15356
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Basic UDI-DI |
|
Seadme klass |
Meditsiiniseade
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Medical Device Nomenclature |
|
Risk class |
IIa
|
Appliance |
-
|
Device name (in Estonian) |
Tuloc Premium
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Device name (in English) |
Tuloc Premium
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Intended use (is Estonian) |
Toode on ette nähtud mittepalpeeritavate rinnanäärme kahjustuste operatsioonieelseks markeerimiseks, et hõlbustada kirurgil kahjustuse asukoha leidmist operatsiooni ajal.
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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.
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Type/model/article number |
271880, 271881, 271883
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Notified body |
0482
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Manufacturer |
Somatex Medical Technologies GmbH
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In register from |
07/31/2020
|
Entry status |
Active
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Reimbursed by EHIF |
Tervisekassa soodustus puudub
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