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    <tradeName>Sphera 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>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:53:15.030Z</lastUpdated>
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    <basicUdiDi>B-07898497043753</basicUdiDi>
    <tradeName>SPHERA DUO  ADULT ( SEPARATED COMPONENTS)</tradeName>
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    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
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    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <basicUdiDi>B-07898497043500</basicUdiDi>
    <tradeName>Sphera Adult Unishunt</tradeName>
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    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
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    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <emdnDescription></emdnDescription>
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    <lastUpdated>2026-09-21T23:53:13.042Z</lastUpdated>
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    <basicUdiDi>B-07898497041889</basicUdiDi>
    <tradeName>Sphera Adult</tradeName>
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    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADA10223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:53:11.776Z</lastUpdated>
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    <basicUdiDi>B-07898497043760</basicUdiDi>
    <tradeName>SPHERA DUO  ADULT ( 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>ADM12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:53:11.296Z</lastUpdated>
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    <udiDi>07898497043777</udiDi>
    <basicUdiDi>B-07898497043777</basicUdiDi>
    <tradeName>SPHERA DUO  ADULT ( 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>ADA12023D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:53:10.278Z</lastUpdated>
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    <udiDi>07898497043272</udiDi>
    <basicUdiDi>B-07898497043272</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>ADE12015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:59.393Z</lastUpdated>
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    <udiDi>07898497043524</udiDi>
    <basicUdiDi>B-07898497043524</basicUdiDi>
    <tradeName>Sphera 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>UNADB10213</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:58.807Z</lastUpdated>
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    <udiDi>07898497043289</udiDi>
    <basicUdiDi>B-07898497043289</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>ADB12015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:58.327Z</lastUpdated>
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    <udiDi>07898497043531</udiDi>
    <basicUdiDi>B-07898497043531</basicUdiDi>
    <tradeName>Sphera 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>UNADM10213</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:57.990Z</lastUpdated>
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    <udiDi>07898497043548</udiDi>
    <basicUdiDi>B-07898497043548</basicUdiDi>
    <tradeName>Sphera 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>UNADA10213</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:56.039Z</lastUpdated>
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    <udiDi>07898497043296</udiDi>
    <basicUdiDi>B-07898497043296</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>ADM12015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:55.613Z</lastUpdated>
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    <udiDi>07898497043517</udiDi>
    <basicUdiDi>B-07898497043517</basicUdiDi>
    <tradeName>Sphera 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>UNADE10213</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:54.699Z</lastUpdated>
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    <udiDi>07898497043302</udiDi>
    <basicUdiDi>B-07898497043302</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>ADA12015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:40.557Z</lastUpdated>
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    <udiDi>07898497043319</udiDi>
    <basicUdiDi>B-07898497043319</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>ADE12023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:40.060Z</lastUpdated>
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    <udiDi>07898497043326</udiDi>
    <basicUdiDi>B-07898497043326</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>ADB12023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:38.548Z</lastUpdated>
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    <udiDi>07898497043333</udiDi>
    <basicUdiDi>B-07898497043333</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>ADM12023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:37.410Z</lastUpdated>
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    <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>ADA12023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:24.745Z</lastUpdated>
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    <udiDi>07898497041773</udiDi>
    <basicUdiDi>B-07898497041773</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>ADE9015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:23.381Z</lastUpdated>
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    <udiDi>07898497042138</udiDi>
    <basicUdiDi>B-07898497042138</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>UADE10210D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T23:52:19.926Z</lastUpdated>
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