<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>07898497044125</udiDi>
    <basicUdiDi>B-07898497044125</basicUdiDi>
    <tradeName>SPHERA PRO + SPHERA GRAV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000048434</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UPRO12023-G25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:13:48.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497044132</udiDi>
    <basicUdiDi>B-07898497044132</basicUdiDi>
    <tradeName>SPHERA PRO + SPHERA GRAV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000048434</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UPRO12023-G30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:13:47.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497044149</udiDi>
    <basicUdiDi>B-07898497044149</basicUdiDi>
    <tradeName>SPHERA PRO + SPHERA GRAV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000048434</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UPRO12023-G35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:13:46.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497046280</udiDi>
    <basicUdiDi>B-07898497046280</basicUdiDi>
    <tradeName>07898497046280</tradeName>
    <deviceName>PERITONEAL CATHETER PASSER HPBIO 50 CM</deviceName>
    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000048434</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TZCI50</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-11T03:50:13.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497046303</udiDi>
    <basicUdiDi>B-07898497046303</basicUdiDi>
    <tradeName>07898497046303</tradeName>
    <deviceName>PERITONEAL CATHETER PASSER HPBIO 35 CM</deviceName>
    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000048434</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TZCI35</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-07T20:30:43.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497046242</udiDi>
    <basicUdiDi>789849704REGPRO7U</basicUdiDi>
    <tradeName>PROGRAMMING DEVICE FOR SPHERA PRO PROGRAMMABLE VALVE REG-PRO</tradeName>
    <deviceName>PROGRAMMING DEVICE FOR SPHERA PRO PROGRAMMABLE VALVE REG-PRO</deviceName>
    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000048434</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REG-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:12:35.084Z</lastUpdated>
  </row>
</eudamedExport>