<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07898497045245</udiDi>
    <basicUdiDi>B-07898497045245</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPB12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:20:21.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045221</udiDi>
    <basicUdiDi>B-07898497045221</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPA12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:59.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497046211</udiDi>
    <basicUdiDi>B-07898497046211</basicUdiDi>
    <tradeName>Sphera Duo Neonatal with Reservoir Unishunt</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>UNNE12023RD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:58.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045290</udiDi>
    <basicUdiDi>B-07898497045290</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPE12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:58.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497046204</udiDi>
    <basicUdiDi>B-07898497046204</basicUdiDi>
    <tradeName>Sphera Duo Neonatal with Reservoir Unishunt</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>UNNB12023RD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:57.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045283</udiDi>
    <basicUdiDi>B-07898497045283</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPB12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:57.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497044958</udiDi>
    <basicUdiDi>B-07898497044958</basicUdiDi>
    <tradeName>SPHERA DUO NEONATAL PLUS</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>NPM10223D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:56.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497046198</udiDi>
    <basicUdiDi>B-07898497046198</basicUdiDi>
    <tradeName>Sphera Duo Neonatal with Reservoir Unishunt</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>UNNM12023RD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:56.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045276</udiDi>
    <basicUdiDi>B-07898497045276</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPM12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:40.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497044941</udiDi>
    <basicUdiDi>B-07898497044941</basicUdiDi>
    <tradeName>SPHERA DUO NEONATAL PLUS</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>NPA10223D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:40.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497046181</udiDi>
    <basicUdiDi>B-07898497046181</basicUdiDi>
    <tradeName>Sphera Duo Neonatal with Reservoir Unishunt</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>UNNA12023R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:39.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045269</udiDi>
    <basicUdiDi>B-07898497045269</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPA12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:38.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045337</udiDi>
    <basicUdiDi>B-07898497045337</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPE9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:36.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045320</udiDi>
    <basicUdiDi>B-07898497045320</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPB9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:19:17.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045016</udiDi>
    <basicUdiDi>B-07898497045016</basicUdiDi>
    <tradeName>SPHERA DUO NEONATAL PLUS</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>NPE12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:18:41.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045313</udiDi>
    <basicUdiDi>B-07898497045313</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPM9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:18:13.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045306</udiDi>
    <basicUdiDi>B-07898497045306</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPA9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:18:12.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045009</udiDi>
    <basicUdiDi>B-07898497045009</basicUdiDi>
    <tradeName>SPHERA DUO NEONATAL PLUS</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>NPB12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:18:12.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497045375</udiDi>
    <basicUdiDi>B-07898497045375</basicUdiDi>
    <tradeName>Sphera Duo Neonatal Plus Unishunt</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>UNPE9023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:18:11.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497044996</udiDi>
    <basicUdiDi>B-07898497044996</basicUdiDi>
    <tradeName>SPHERA DUO NEONATAL PLUS</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>NPM12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:18:11.318Z</lastUpdated>
  </row>
</eudamedExport>