<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809766326520</udiDi>
    <basicUdiDi>880936647KM01MT</basicUdiDi>
    <tradeName>MONOFIX PDO</tradeName>
    <deviceName>Absorbable Knotless Wound Closure Device</deviceName>
    <manufacturerName>Samyang Biopharm Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000037085</manufacturerSrn>
    <authorisedRepresentativeName>Samyang Biopharm Magyarország Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000035346</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010101010104</emdnCode>
    <emdnDescription>MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>KM0411SA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:54:29.211Z</lastUpdated>
  </row>
</eudamedExport>