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Terviseamet

Medical device

MSA code 16966
UDI code
Seadme klass Meditsiiniseade
Risk class IIa
Appliance -
Device name (in Estonian) Episealer Knee Implant Accessories
Device name (in English) Episealer Knee Implant Accessories
Intended use (is Estonian) Episealer Knee Implant (edaspidi ka Episealer) on individualiseeritud endoproteetiline pinnakatte
implantaat, mis on ette nähtud kõhre ja luu asendamiseks põlve luuploki (trochlea) kondraalsete ja
osteokondraalsete defektide korral, kattes osa liigest. See on ette nähtud patsiendile põlve parema
funktsiooni andmiseks ja valu leevendamiseks. Seda saab kasutada reieluu ja põlve liigesel eri
suurusega lesioonide ja degeneratiivse või traumaatilise etioloogiaga lesioonide korral.
Intended use (in English) The Episealer Knee Implant (hereinafter also referred to as Episealer) is an individualised endoprosthetic resurfacing implant, intended to be used as cartilage and bone replacement for
knee trochlea chondral and osteochondral defects, covering a part of the joint. It is intended to
give the patient improved knee function and pain relief. It is applicable on the femoral knee joint,
for different lesion sizes and lesions of degenerative or traumatic etiology.
Type/model/article number Article numbers for the Episealer Knee Implant Accessories is presented in document "Article Numbers Episealer Knee Implant Accessories"
Additional information The Episealer Knee Implant Accessories can be delivered sterile or non-sterile, hence the different IFUs.
Notified body 0344
Manufacturer Episurf Operations AB
In register from 10/13/2021
Status Active
EHK soodustus EHK soodustus puudub
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