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    <tradeName>Sphera Duo Adult 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>UADM10223D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:02.536Z</lastUpdated>
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    <udiDi>07898497042336</udiDi>
    <basicUdiDi>B-07898497042336</basicUdiDi>
    <tradeName>SPHERA DUO INFANTILE (SEPARATED COMPONENTS)</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>INE907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:02.237Z</lastUpdated>
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    <udiDi>07898497043173</udiDi>
    <basicUdiDi>B-07898497043173</basicUdiDi>
    <tradeName>Sphera Duo Infantile (valve only)</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>SDVINB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:02.121Z</lastUpdated>
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    <udiDi>07898497043814</udiDi>
    <basicUdiDi>B-07898497043814</basicUdiDi>
    <tradeName>Sphera Duo Adult 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>UADA10223D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:02.083Z</lastUpdated>
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    <udiDi>07898497042251</udiDi>
    <basicUdiDi>B-07898497042251</basicUdiDi>
    <tradeName>Sphera Duo Adult 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>UADE12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:01.545Z</lastUpdated>
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    <udiDi>07898497042343</udiDi>
    <basicUdiDi>B-07898497042343</basicUdiDi>
    <tradeName>SPHERA DUO INFANTILE (SEPARATED COMPONENTS)</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>INB907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:01.512Z</lastUpdated>
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  <row>
    <udiDi>07898497041919</udiDi>
    <basicUdiDi>B-07898497041919</basicUdiDi>
    <tradeName>Sphera Duo</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>ADM9010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:01.331Z</lastUpdated>
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    <udiDi>07898497042350</udiDi>
    <basicUdiDi>B-07898497042350</basicUdiDi>
    <tradeName>SPHERA DUO INFANTILE (SEPARATED COMPONENTS)</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>INM907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:49.934Z</lastUpdated>
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  <row>
    <udiDi>07898497042268</udiDi>
    <basicUdiDi>B-07898497042268</basicUdiDi>
    <tradeName>Sphera Duo Adult 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>UADB12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:49.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497041995</udiDi>
    <basicUdiDi>B-07898497041995</basicUdiDi>
    <tradeName>Sphera Adult</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>ADM10210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:49.724Z</lastUpdated>
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    <udiDi>07898497042275</udiDi>
    <basicUdiDi>B-07898497042275</basicUdiDi>
    <tradeName>Sphera Duo Adult 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>UADM12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:49.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497043166</udiDi>
    <basicUdiDi>B-07898497043166</basicUdiDi>
    <tradeName>Sphera Duo Infantile (valve only)</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>SDVINM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:49.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898497042282</udiDi>
    <basicUdiDi>B-07898497042282</basicUdiDi>
    <tradeName>Sphera Duo Adult 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>UADA12015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:48.951Z</lastUpdated>
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  <row>
    <udiDi>07898497042367</udiDi>
    <basicUdiDi>B-07898497042367</basicUdiDi>
    <tradeName>SPHERA DUO INFANTILE (SEPARATED COMPONENTS)</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>INA907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:48.739Z</lastUpdated>
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  <row>
    <udiDi>07898497043159</udiDi>
    <basicUdiDi>B-07898497043159</basicUdiDi>
    <tradeName>Sphera Duo Infantile (valve only)</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>SDVINA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:48.469Z</lastUpdated>
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  <row>
    <udiDi>07898497043821</udiDi>
    <basicUdiDi>B-07898497043821</basicUdiDi>
    <tradeName>Sphera Duo Adult 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>UADE12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:48.450Z</lastUpdated>
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  <row>
    <udiDi>07898497043838</udiDi>
    <basicUdiDi>B-07898497043838</basicUdiDi>
    <tradeName>Sphera Duo Adult 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>UADB12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:47.998Z</lastUpdated>
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    <udiDi>07898497042657</udiDi>
    <basicUdiDi>B-07898497042657</basicUdiDi>
    <tradeName>Sphera Duo Neonatal</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>NNE905D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:46.601Z</lastUpdated>
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    <udiDi>07898497043869</udiDi>
    <basicUdiDi>B-07898497043869</basicUdiDi>
    <tradeName>Sphera Duo Adult Unitized</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>UNADE10213D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:46.129Z</lastUpdated>
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  <row>
    <udiDi>07898497042664</udiDi>
    <basicUdiDi>B-07898497042664</basicUdiDi>
    <tradeName>Sphera Duo Neonatal</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>NNB905D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:44.358Z</lastUpdated>
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