|
|
| EMDDB code |
22247
|
| Basic UDI-DI |
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IIa
|
| Appliance |
-
|
| Device name (in Estonian) |
PTFE juhttraadid
|
| Device name (in English) |
PTFE Guidewire
|
| Intended use (is Estonian) |
Juhttraate kasutatakse kuseteede esmaseks ligipääsuks, raja loomiseks teistele uroloogilistele
seadmetele ja seadmete vahetamise hõlbustamiseks uroloogiliste protseduuride ajal.
|
| Intended use (in English) |
The guidewires are used to provide initial access to the
urinary system, establish a track for other urological
devices and to facilitate exchange of devices during
urological procedures.
|
| Type/model/article number |
22BX, 24BX, 25BX, 26BX, 28BX, 29BX
|
| Notified body |
0344
|
| Manufacturer |
Gyrus ACMI, Inc.
|
| Authorised representative |
Olympus Europa SE & Co. KG
|
| In register from |
06/17/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDD
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
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