<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03701700817529</udiDi>
    <basicUdiDi>37017008BITD006Z</basicUdiDi>
    <tradeName>BILIRUBIN TOTAL 4+1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BITD-6400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:54.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414614922</udiDi>
    <basicUdiDi>0405686902240V7</basicUdiDi>
    <tradeName>Atellica CH Diazo Total Bilirubin (D_TBil)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_D_Tbil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:43.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414614755</udiDi>
    <basicUdiDi>0405686902239VN</basicUdiDi>
    <tradeName>Atellica CH Diazo Direct Bilirubin (D_DBil)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_D_Dbil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537219</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:39.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595818</udiDi>
    <basicUdiDi>0405686901869WN</basicUdiDi>
    <tradeName>Atellica CH Total Bilirubin_2 (TBIL_2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_TBIL_2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097531</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:40.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768020544</udiDi>
    <basicUdiDi>0405686901192VE</basicUdiDi>
    <tradeName>Dimension Total Bilirubin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_TBI</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444957</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:05.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB601W6</udiDi>
    <basicUdiDi>B-TB601W6</basicUdiDi>
    <tradeName>Total Bilirubin Reagent Kit</tradeName>
    <deviceName>Total Bilirubin Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB6011Y, TB6012Y, TB6013Y, TB6014Y, TB6015Y, TB6011N, TB6012N, TB6013N, TB6014N, TB6015N TB6021Y, TB6022Y</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:02.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB-V601T9</udiDi>
    <basicUdiDi>B-TB-V601T9</basicUdiDi>
    <tradeName>Total Bilirubin Reagent Kit</tradeName>
    <deviceName>Total Bilirubin Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-V6011Y, TB-V6012Y, TB-V6013Y, TB-V6014Y, TB-V6015Y, TB-V6011N, TB-V6012N, TB-V6013N, TB-V6014N, TB-V6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:56.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010500355</udiDi>
    <basicUdiDi>B-ECH010500355</basicUdiDi>
    <tradeName>D-ECH010500355</tradeName>
    <deviceName>Total Bilirubin (TBil)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:08.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010500457</udiDi>
    <basicUdiDi>B-ECH010500457</basicUdiDi>
    <tradeName>D-ECH010500457</tradeName>
    <deviceName>Direct Bilirubin (DBil)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:05.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010044B</udiDi>
    <basicUdiDi>B-ECH01010044B</basicUdiDi>
    <tradeName>D-ECH01010044B</tradeName>
    <deviceName>Direct Bilirubin (DBil)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:21.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010100349</udiDi>
    <basicUdiDi>B-ECH010100349</basicUdiDi>
    <tradeName>D-ECH010100349</tradeName>
    <deviceName>Total Bilirubin (TBil)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:17.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DB601QN</udiDi>
    <basicUdiDi>B-DB601QN</basicUdiDi>
    <tradeName>Direct Bilirubin Reagent Kit</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB6011Y, DB6012Y, DB6013Y, DB6014Y, DB6015Y, DB6011N, DB6012N, DB6013N, DB6014N, DB6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:16.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DB-V601JR</udiDi>
    <basicUdiDi>B-DB-V601JR</basicUdiDi>
    <tradeName>Direct Bilirubin Reagent Kit</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB-V6011Y, DB-V6012Y, DB-V6013Y, DB-V6014Y, DB-V6015Y, DB-V6011N, DB-V6012N, DB-V6013N, DB-V6014N, DB-V6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:11.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0165LM</udiDi>
    <basicUdiDi>B-C0165LM</basicUdiDi>
    <tradeName>Total Bilirubin</tradeName>
    <deviceName>Total Bilirubin</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0165</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:25.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0164LK</udiDi>
    <basicUdiDi>B-C0164LK</basicUdiDi>
    <tradeName>Direct Bilirubin</tradeName>
    <deviceName>Direct Bilirubin</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0164</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:23.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BilirubinQL</udiDi>
    <basicUdiDi>B-BilirubinQL</basicUdiDi>
    <tradeName>Bilirubin</tradeName>
    <deviceName>Bilirubin</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Bil-Mc-02100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:31:58.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BILIRUBINA-TOTALE-LR4R</udiDi>
    <basicUdiDi>B-BILIRUBINA-TOTALE-LR4R</basicUdiDi>
    <tradeName>BILIRUBINA-TOTALE-LR</tradeName>
    <deviceName>BILIRUBINA-TOTALE-LR reattivo liquido</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC223-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:39.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BILIRUBINA-DIRETTA-LRGX</udiDi>
    <basicUdiDi>B-BILIRUBINA-DIRETTA-LRGX</basicUdiDi>
    <tradeName>BILIRUBINA DIRETTA LR</tradeName>
    <deviceName>BILIRUBINA DIRETTA LR REATTIVO LIQUIDO</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:38.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>80536177202692H</udiDi>
    <basicUdiDi>B-80536177202692H</basicUdiDi>
    <tradeName>C4 Antibody</tradeName>
    <deviceName>C4 Antibody</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB1113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:32:50.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>805361772024523</udiDi>
    <basicUdiDi>B-805361772024523</basicUdiDi>
    <tradeName>Bilirubin T+D LS Gen. 2</tradeName>
    <deviceName>Bilirubin T+D LS Gen. 2</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC1039</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:32:30.953Z</lastUpdated>
  </row>
</eudamedExport>