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    <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>UNADB10213D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:44.145Z</lastUpdated>
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    <udiDi>07898497043203</udiDi>
    <basicUdiDi>B-07898497043203</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>UNADM10213D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:30.514Z</lastUpdated>
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    <udiDi>07898497042671</udiDi>
    <basicUdiDi>B-07898497042671</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>NNM905D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:30.475Z</lastUpdated>
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    <udiDi>07898497043234</udiDi>
    <basicUdiDi>B-07898497043234</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>UNADA10213D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:30.234Z</lastUpdated>
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    <udiDi>07898497042688</udiDi>
    <basicUdiDi>B-07898497042688</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>NNA905D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:29.794Z</lastUpdated>
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    <udiDi>07898497044705</udiDi>
    <basicUdiDi>B-07898497044705</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINE907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:28.958Z</lastUpdated>
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    <udiDi>07898497042381</udiDi>
    <basicUdiDi>B-07898497042381</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINB907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:28.550Z</lastUpdated>
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    <udiDi>07898497042398</udiDi>
    <basicUdiDi>B-07898497042398</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINM907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:28.433Z</lastUpdated>
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  <row>
    <udiDi>07898497042404</udiDi>
    <basicUdiDi>B-07898497042404</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINA907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:28.186Z</lastUpdated>
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  <row>
    <udiDi>07898497042459</udiDi>
    <basicUdiDi>B-07898497042459</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINE9010D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:27.662Z</lastUpdated>
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  <row>
    <udiDi>07898497042466</udiDi>
    <basicUdiDi>B-07898497042466</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINB9010D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:27.449Z</lastUpdated>
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  <row>
    <udiDi>07898497042473</udiDi>
    <basicUdiDi>B-07898497042473</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINM9010D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:27.330Z</lastUpdated>
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  <row>
    <udiDi>07898497042480</udiDi>
    <basicUdiDi>B-07898497042480</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINA9010D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:51:27.247Z</lastUpdated>
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  <row>
    <udiDi>07898497042299</udiDi>
    <basicUdiDi>B-07898497042299</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINE9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:50:27.489Z</lastUpdated>
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  <row>
    <udiDi>07898497042305</udiDi>
    <basicUdiDi>B-07898497042305</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINB9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:50:26.117Z</lastUpdated>
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  <row>
    <udiDi>07898497042312</udiDi>
    <basicUdiDi>B-07898497042312</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINM9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:50:25.859Z</lastUpdated>
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  <row>
    <udiDi>07898497042329</udiDi>
    <basicUdiDi>B-07898497042329</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINA9015D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:50:25.680Z</lastUpdated>
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    <udiDi>07898497041056</udiDi>
    <basicUdiDi>B-07898497041056</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>NNE907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:35:07.093Z</lastUpdated>
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    <udiDi>07898497041063</udiDi>
    <basicUdiDi>B-07898497041063</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>NNB907D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:34:49.753Z</lastUpdated>
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    <udiDi>07898497043685</udiDi>
    <basicUdiDi>B-07898497043685</basicUdiDi>
    <tradeName>Sphera Duo Infantile 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>UINE9023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:34:45.838Z</lastUpdated>
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