<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056336800215</udiDi>
    <basicUdiDi>50563368AAAIVDSC0013Q</basicUdiDi>
    <tradeName>Bio30+ Physio Accel W/O A/S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biochrom Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025158</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-6000-52</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:23.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056336800222</udiDi>
    <basicUdiDi>50563368AAAIVDSC0013Q</basicUdiDi>
    <tradeName>Bio 30+ System Physio HP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biochrom Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025158</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-6000-53</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:23.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056336800239</udiDi>
    <basicUdiDi>50563368AAAIVDSC0013Q</basicUdiDi>
    <tradeName>Bio 30+ Sys Physio HP EZ Nin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biochrom Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025158</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-6000-53EZ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:23.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056336800253</udiDi>
    <basicUdiDi>50563368AAAIVDSC0013Q</basicUdiDi>
    <tradeName>Bio 30+ Physio W/O A/S HP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biochrom Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025158</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-6000-55</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:23.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056336800260</udiDi>
    <basicUdiDi>50563368AAAIVDSC0013Q</basicUdiDi>
    <tradeName>Bio 30+ System Physio HR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biochrom Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025158</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-6000-56</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:23.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056336800277</udiDi>
    <basicUdiDi>50563368AAAIVDSC0013Q</basicUdiDi>
    <tradeName>Bio 30+ Physiological HR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biochrom Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025158</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-6000-57</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:23.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056336800284</udiDi>
    <basicUdiDi>50563368AAAIVDSC0013Q</basicUdiDi>
    <tradeName>Bio 30+ Physio W/O A/S HR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biochrom Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025158</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-6000-58</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:23.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895302698</udiDi>
    <basicUdiDi>6936895BS00326</basicUdiDi>
    <tradeName>Automatic Chemistry Analyzer</tradeName>
    <deviceName>Automatic Chemistry Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010102</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:27:02.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895302681</udiDi>
    <basicUdiDi>6936895BS00326</basicUdiDi>
    <tradeName>Automatic Chemistry Analyzer</tradeName>
    <deviceName>Automatic Chemistry Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:17:15.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>16934175044457</udiDi>
    <basicUdiDi>6934175002A0002NG</basicUdiDi>
    <tradeName>Portable Automatic Multi-Function Analyzer (iCARE-1300)</tradeName>
    <deviceName>Portable Automatic Multi-Function Analyzer</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10500077</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:12:15.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939184631516</udiDi>
    <basicUdiDi>6939184630001BD</basicUdiDi>
    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Bioland Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010625</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-427B</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:11:20.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247281354</udiDi>
    <basicUdiDi>69382472Rinse-23MN</basicUdiDi>
    <tradeName>06938247281354</tradeName>
    <deviceName>Rinse Solution</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8065E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:10:04.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247281330</udiDi>
    <basicUdiDi>69382472CleanII-22T9</basicUdiDi>
    <tradeName>06938247281330</tradeName>
    <deviceName>Clean II</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8063E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:10:03.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247255010</udiDi>
    <basicUdiDi>69382472U55E-19H3</basicUdiDi>
    <tradeName>06938247255010</tradeName>
    <deviceName>Automated Coagulation Analyzer</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U55E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:10:02.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247250060</udiDi>
    <basicUdiDi>69382472U50E-18FA</basicUdiDi>
    <tradeName>06938247250060</tradeName>
    <deviceName>Automated Coagulation Analyzer</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U50E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:09:59.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247230086</udiDi>
    <basicUdiDi>69382472U30E-17EE</basicUdiDi>
    <tradeName>06938247230086</tradeName>
    <deviceName>Automated Coagulation Analyzer</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U30E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:09:59.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247225211</udiDi>
    <basicUdiDi>69382472UG251E-61VC</basicUdiDi>
    <tradeName>06938247225211</tradeName>
    <deviceName>Automated Coagulation Analyzer</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UG251E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:09:57.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247225204</udiDi>
    <basicUdiDi>69382472UG25E-60QX</basicUdiDi>
    <tradeName>06938247225204</tradeName>
    <deviceName>Automated Coagulation Analyzer</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UG25E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:09:56.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247222265</udiDi>
    <basicUdiDi>69382472CleanI-21WC</basicUdiDi>
    <tradeName>06938247222265</tradeName>
    <deviceName>Clean I</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2060E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:09:52.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938247215014</udiDi>
    <basicUdiDi>69382472U15E-16F9</basicUdiDi>
    <tradeName>06938247215014</tradeName>
    <deviceName>Automated Coagulation Analyzer</deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U15E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:09:51.272Z</lastUpdated>
  </row>
</eudamedExport>