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| EMDDB code |
23820
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| Basic UDI-DI |
37013875474NX
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| Seadme klass |
Meditsiiniseade
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| Medical Device Nomenclature |
|
| Risk class |
IIb
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| Appliance |
-
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| Device name (in Estonian) |
PERALEX 9 HECTO+
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| Device name (in English) |
PERALEX 9 HECTO+
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| Intended use (is Estonian) |
Meditsiiniseade, mis on mõeldud kasutamiseks ainult spetsialistide poolt invasiivsete ja mitteinvasiivsete temperatuuritundlike meditsiiniseadmete kõrgetasemelise desinfitseerimiseks, mis nõuavad desinfitseerimist vastavalt kasutusjuhendile, nagu endoskoobid ja kirurgilised instrumendid.
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| Intended use (in English) |
Medical device for exclusive use by profesionals for high level disinfection of invasive and non invasive temperature sensitve medical devices requiring disinfection according to their instructions for use such as scopes and surgical instruments.
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| Type/model/article number |
5L : 1047405
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| Notified body |
0459
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| Manufacturer |
FRANKLAB
|
| In register from |
04/08/2026
|
| Entry status |
Active
|
| Device comments, keywords |
MDD
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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