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    <tradeName>Total Bilirubin (TBIL) Test Kit (DCA)</tradeName>
    <deviceName>Total Bilirubin (TBIL) Test Kit (DCA)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:80mL×2  R2:20mL×2（706）</reference>
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    <lastUpdated>2026-07-06T10:16:29.575Z</lastUpdated>
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    <udiDi>06971674862611</udiDi>
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    <tradeName>Total Bilirubin (TBIL) Test Kit (DCA)</tradeName>
    <deviceName>Total Bilirubin (TBIL) Test Kit (DCA)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <tradeName>Total Bilirubin (TBIL) Test Kit (DCA)</tradeName>
    <deviceName>Total Bilirubin (TBIL) Test Kit (DCA)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:16:26.373Z</lastUpdated>
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    <tradeName>Total Bilirubin (TBIL) Test Kit (DCA)</tradeName>
    <deviceName>Total Bilirubin (TBIL) Test Kit (DCA)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:16:22.401Z</lastUpdated>
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    <udiDi>06971674862598</udiDi>
    <basicUdiDi>B-06971674862598</basicUdiDi>
    <tradeName>Total Bilirubin (TBIL) Test Kit (DCA)</tradeName>
    <deviceName>Total Bilirubin (TBIL) Test Kit (DCA)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×1  R2:5mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:16:19.736Z</lastUpdated>
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    <udiDi>06971674862581</udiDi>
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    <tradeName>Total Bilirubin (TBIL) Test Kit (DCA)</tradeName>
    <deviceName>Total Bilirubin (TBIL) Test Kit (DCA)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:16:19.073Z</lastUpdated>
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    <udiDi>06971674862574</udiDi>
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    <tradeName>Total Bilirubin (TBIL) Test Kit (DCA)</tradeName>
    <deviceName>Total Bilirubin (TBIL) Test Kit (DCA)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×2  R2:16mL×2（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:16:19.065Z</lastUpdated>
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    <udiDi>06944904025216</udiDi>
    <basicUdiDi>694490400045Bil-T(VOX)*F4</basicUdiDi>
    <tradeName>Bilirubin Total Kit (VOX Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000865-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:11:02.023Z</lastUpdated>
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    <udiDi>06944904025223</udiDi>
    <basicUdiDi>694490400045Bil-D(VOX)*6L</basicUdiDi>
    <tradeName>Bilirubin Direct Kit (VOX Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000866-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:11:01.995Z</lastUpdated>
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    <udiDi>06944904050768</udiDi>
    <basicUdiDi>694490400045Bil-T(VOX)*F4</basicUdiDi>
    <tradeName>Bilirubin Total Kit (VOX Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004598-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:29.088Z</lastUpdated>
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    <udiDi>06944904050775</udiDi>
    <basicUdiDi>694490400045Bil-D(VOX)*6L</basicUdiDi>
    <tradeName>Bilirubin Direct Kit (VOX Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004599-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:29.066Z</lastUpdated>
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    <udiDi>03610230005026</udiDi>
    <basicUdiDi>B-03610230005026</basicUdiDi>
    <tradeName>ABX Pentra Bilirubin, Total CP</tradeName>
    <deviceName>ABX Pentra Bilirubin, Total CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01639</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:59:21.092Z</lastUpdated>
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    <udiDi>03610230004982</udiDi>
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    <tradeName>ABX Pentra Bilirubin, Direct CP</tradeName>
    <deviceName>ABX Pentra Bilirubin, Direct CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01635</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:59:16.289Z</lastUpdated>
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    <tradeName>06935740711661</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit (Vanadate Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>BILIRUBIN</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:08.863Z</lastUpdated>
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    <tradeName>06935740711647</tradeName>
    <deviceName>Total Bilirubin Reagent Kit (Vanadate Method)</deviceName>
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    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
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    <tradeName>Bilirubin Total (DCA)</tradeName>
    <deviceName>Bilirubin Total (DCA)</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981952</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:06:00.840Z</lastUpdated>
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    <deviceName>Bilirubina bezp. BM 100 / BM 200</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
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    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T02:28:12.055Z</lastUpdated>
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    <deviceName>Bilirubina całkowita DMSO 3x100 ml</deviceName>
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    <deviceName>Bilirubina całk. BM 100 / BM 200</deviceName>
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    <tradeName>DIRECT BILIRUBIN</tradeName>
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    <manufacturerName>Medicon Hellas SA</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0159</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:18.786Z</lastUpdated>
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