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<eudamedExport entity="devices">
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    <udiDi>08034063843221</udiDi>
    <basicUdiDi>B-08034063843221</basicUdiDi>
    <tradeName>Direct BILIRUBIN</tradeName>
    <deviceName>Direct BILIRUBIN</deviceName>
    <manufacturerName>FAR Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL08-110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-20T20:01:38.559Z</lastUpdated>
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    <udiDi>06936895305347</udiDi>
    <basicUdiDi>B-06936895305347</basicUdiDi>
    <tradeName>Direct Bilirubin (DBIL) Test Kit (DCA)</tradeName>
    <deviceName>Direct Bilirubin (DBIL) 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>R1:64mL×2  R2:16mL×2（794）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:40:06.756Z</lastUpdated>
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  <row>
    <udiDi>06936895305354</udiDi>
    <basicUdiDi>B-06936895305354</basicUdiDi>
    <tradeName>Direct Bilirubin (DBIL) Test Kit (DCA)</tradeName>
    <deviceName>Direct Bilirubin (DBIL) 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（710）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:40:04.461Z</lastUpdated>
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  <row>
    <udiDi>62230182704094</udiDi>
    <basicUdiDi>B-62230182704094</basicUdiDi>
    <tradeName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</tradeName>
    <deviceName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-610 004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:32:50.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182703936</udiDi>
    <basicUdiDi>B-62230182703936</basicUdiDi>
    <tradeName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</tradeName>
    <deviceName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-610 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:32:47.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182703868</udiDi>
    <basicUdiDi>B-62230182703868</basicUdiDi>
    <tradeName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</tradeName>
    <deviceName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-610 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:32:45.388Z</lastUpdated>
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  <row>
    <udiDi>62230182703790</udiDi>
    <basicUdiDi>B-62230182703790</basicUdiDi>
    <tradeName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</tradeName>
    <deviceName>Total Bilirubin (Single Reagent) MODIFIED BERGH &amp; MÜLLER METHOD</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-610 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:32:44.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182703622</udiDi>
    <basicUdiDi>B-62230182703622</basicUdiDi>
    <tradeName>Pediatric Total Bilirubin</tradeName>
    <deviceName>Pediatric Total Bilirubin</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-663 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:32:43.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182701260</udiDi>
    <basicUdiDi>B-62230182701260</basicUdiDi>
    <tradeName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</tradeName>
    <deviceName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-609 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:31:53.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182701192</udiDi>
    <basicUdiDi>B-62230182701192</basicUdiDi>
    <tradeName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</tradeName>
    <deviceName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-609 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:31:47.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182701024</udiDi>
    <basicUdiDi>B-62230182701024</basicUdiDi>
    <tradeName>Bilirubin (Total &amp; Direct) DMSO, Colorimetric</tradeName>
    <deviceName>Bilirubin (Total &amp; Direct) DMSO, Colorimetric</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-658 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:31:46.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182700102</udiDi>
    <basicUdiDi>B-62230182700102</basicUdiDi>
    <tradeName>Bilirubin Direct</tradeName>
    <deviceName>Bilirubin Direct</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-657 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:31:31.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041035444</udiDi>
    <basicUdiDi>B-62230041035444</basicUdiDi>
    <tradeName>Bilirubin Total - single reagent</tradeName>
    <deviceName>Bilirubin Total - single reagent</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:27:33.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041035376</udiDi>
    <basicUdiDi>B-62230041035376</basicUdiDi>
    <tradeName>Bilirubin Total - single reagent</tradeName>
    <deviceName>Bilirubin Total - single reagent</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:27:31.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041009940</udiDi>
    <basicUdiDi>B-62230041009940</basicUdiDi>
    <tradeName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</tradeName>
    <deviceName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:21:19.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041009872</udiDi>
    <basicUdiDi>B-62230041009872</basicUdiDi>
    <tradeName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</tradeName>
    <deviceName>Bilirubin (TOTAL AND DIRECT) Jendrassik Grof</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:21:18.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041009704</udiDi>
    <basicUdiDi>B-62230041009704</basicUdiDi>
    <tradeName>Bilirubin Total/Direct DMSO</tradeName>
    <deviceName>Bilirubin Total/Direct DMSO</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:21:18.256Z</lastUpdated>
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  <row>
    <udiDi>62230041009636</udiDi>
    <basicUdiDi>B-62230041009636</basicUdiDi>
    <tradeName>Bilirubin (Direct)</tradeName>
    <deviceName>Bilirubin (Direct)</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>224 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:21:14.113Z</lastUpdated>
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  <row>
    <udiDi>D-6-15A7</udiDi>
    <basicUdiDi>B-6-15A7</basicUdiDi>
    <tradeName>D-6-15A7</tradeName>
    <deviceName>Total Bilirubin Reagent kit (Dichloroaniline Diazo Salt 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U81482040M, U81489060M, U81485020M, U81411020M, U81420060M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:12.264Z</lastUpdated>
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  <row>
    <udiDi>D-6-14A5</udiDi>
    <basicUdiDi>B-6-14A5</basicUdiDi>
    <tradeName>D-6-14A5</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit (Dichloroaniline Diazo Salt 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U81582040M, U81589060M, U81585020M, U81511020M, U81520060M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:05.988Z</lastUpdated>
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</eudamedExport>