EMDDB code |
20748
|
Basic UDI-DI |
5033241CATHETERSVY
|
Seadme klass |
Meditsiiniseade
|
Medical Device Nomenclature |
|
Risk class |
I sterile
|
Appliance |
-
|
Device name (in Estonian) |
Naiste Kateeter
|
Device name (in English) |
Female Catheter
|
Intended use (is Estonian) |
Pennine ajutised uriinikateetrid on ühekordselt kasutatavad elastsed voolikud, mis uriini ajutiseks/lühiajaliseks passiivseks väljutamiseks
sisestatakse kusiti kaudu põide ja eemaldatakse seejärel viivitamatult. Vahend on mõeldud kasutamiseks vähemalt kaheaastastel patsientidel, kes vajavad põie tühjendamist.
|
Intended use (in English) |
Pennine’s Intermittent Urethral Catheters are a single use, flexible tube inserted through the urethra into the bladder for the intermittent/transient passive evacuation of urine, which is then immediately removed. Intended to be used in all patients two years of age and above who require bladder drainage.
|
Type/model/article number |
FC-1418/1
|
Notified body |
2797
|
Manufacturer |
IVOR SHAW LIMITED t/a PENNINE HEALTHCARE
|
Authorised representative |
Advena Ltd.
|
In register from |
07/09/2024
|
Entry status |
Active
|
Reimbursed by EHIF |
Tervisekassa soodustus puudub
|