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Terviseamet

Medical device

MSA code 16965
UDI code
Seadme klass Meditsiiniseade
Risk class IIb
Appliance -
Device name (in Estonian) Episealer Knee Implant
Device name (in English) Episealer Knee Implant
Intended use (is Estonian) Episealer Knee Implant (edaspidi ka Episealer) on individualiseeritud endoproteetiline pinnakatte
implantaat, mis on ette nähtud kõhre ja luu asendamiseks põlve kondüüli 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) 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
condyle 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 11112
11115
11117
11120
31120
31125
31129
51115
51117
51120
51125
Notified body 0344
Manufacturer Episurf Operations AB
In register from 10/13/2021
Status Active
EHK soodustus EHK soodustus puudub
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