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<eudamedExport entity="devices">
  <row>
    <udiDi>06979845480046</udiDi>
    <basicUdiDi>B-06979845480046</basicUdiDi>
    <tradeName>06979845480046</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:47.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480039</udiDi>
    <basicUdiDi>B-06979845480039</basicUdiDi>
    <tradeName>06979845480039</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:46.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996097338</udiDi>
    <basicUdiDi>B-06950996097338</basicUdiDi>
    <tradeName>URcheck Liver Function Lyophilized Kit 12</tradeName>
    <deviceName>URcheck Liver Function Lyophilized Kit 12</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:49.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996060400</udiDi>
    <basicUdiDi>B-06950996060400</basicUdiDi>
    <tradeName>URcheck Health Check Lyophilized Kit 19</tradeName>
    <deviceName>URcheck Health Check Lyophilized Kit 19</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYN-004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:44.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996045995</udiDi>
    <basicUdiDi>B-06950996045995</basicUdiDi>
    <tradeName>URcheck Renal Function Lyophilized Kit 9</tradeName>
    <deviceName>URcheck Renal Function Lyophilized Kit 9</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:43.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996033657</udiDi>
    <basicUdiDi>B-06950996033657</basicUdiDi>
    <tradeName>URcheck Clinical Emergency Lyophilized Kit 12</tradeName>
    <deviceName>URcheck Clinical Emergency Lyophilized Kit 12</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:42.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996022750</udiDi>
    <basicUdiDi>B-06950996022750</basicUdiDi>
    <tradeName>URcheck Cardiovascular Risk Marker Lyophilized Kit 5</tradeName>
    <deviceName>URcheck Cardiovascular Risk Marker Lyophilized Kit 5</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:41.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996011686</udiDi>
    <basicUdiDi>B-06950996011686</basicUdiDi>
    <tradeName>URcheck Electrolytes Lyophilized Kit 9</tradeName>
    <deviceName>URcheck Electrolytes Lyophilized Kit 9</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELE-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:37.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303817</udiDi>
    <basicUdiDi>B-06936895303817</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Slope correction solution B: 350mL（421002）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:32:05.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303800</udiDi>
    <basicUdiDi>B-06936895303800</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Drift correction solution A: 350mL（421001）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:32:04.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303794</udiDi>
    <basicUdiDi>B-06936895303794</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Internal correction solution: 100mL（415005）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:32:03.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303787</udiDi>
    <basicUdiDi>B-06936895303787</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Internal correction solution: 100mL（413005）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:32:01.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303435</udiDi>
    <basicUdiDi>B-06936895303435</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Slope correction solution B: 350mL（445005）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:00.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303428</udiDi>
    <basicUdiDi>B-06936895303428</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Drift correction solution A: 350mL（445004）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:00.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303411</udiDi>
    <basicUdiDi>B-06936895303411</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Filling solution in electrode: 3mL×1（445003）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:56.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303404</udiDi>
    <basicUdiDi>B-06936895303404</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Reference solution:  10mL×1（445001）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:55.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303046</udiDi>
    <basicUdiDi>B-06936895303046</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2 slope calibration solution: 100mL（410010）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:54.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303039</udiDi>
    <basicUdiDi>B-06936895303039</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2 drift calibration solution: 100 mL（410009）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:53.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303022</udiDi>
    <basicUdiDi>B-06936895303022</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer (ISE)</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer (ISE)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Internal correction solution: 100mL（445002）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:49.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895302001</udiDi>
    <basicUdiDi>B-06936895302001</basicUdiDi>
    <tradeName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</tradeName>
    <deviceName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator M:5mL×1（400127）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:41.695Z</lastUpdated>
  </row>
</eudamedExport>