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<eudamedExport entity="devices">
  <row>
    <udiDi>04589448510082</udiDi>
    <basicUdiDi>B-04589448510082</basicUdiDi>
    <tradeName>PL Chip</tradeName>
    <deviceName>PL Chip</deviceName>
    <manufacturerName>ZACROS Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000025159</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020499</emdnCode>
    <emdnDescription>PRIMARY HEMOSTASIS/PLATELET FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:58:29.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768003691</udiDi>
    <basicUdiDi>0405686902013US</basicUdiDi>
    <tradeName>Dade PFA Trigger Solution</tradeName>
    <deviceName>IVDR_27_MAR EB_A_REAG_PFA_TrigSol</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020499</emdnCode>
    <emdnDescription>PRIMARY HEMOSTASIS/PLATELET FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:49.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023859</udiDi>
    <basicUdiDi>0405686900938W9</basicUdiDi>
    <tradeName>INNOVANCE PFA P2Y</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG _INN_PFA_P2Y</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020407</emdnCode>
    <emdnDescription>P2Y12 RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:43.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768003653</udiDi>
    <basicUdiDi>0405686900974WD</basicUdiDi>
    <tradeName>Dade PFA Collagen/EPI Test Cartridge</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_PFA_Coll_ADP_EPI</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:18:39.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195226001204</udiDi>
    <basicUdiDi>0195226001204PZ</basicUdiDi>
    <tradeName>HemosIL CL HIT-IgG(PF4-H)</tradeName>
    <deviceName>HemosIL CL HIT-IgG(PF4-H)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029706200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:05:32.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5618-FGXY</udiDi>
    <basicUdiDi>B-HB-5618-FGXY</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>TRAP-6 MEA</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5618-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:39.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5617-FGXR</udiDi>
    <basicUdiDi>B-HB-5617-FGXR</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Arachidonic Acid MEA</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5617-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:38.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5616-FGXJ</udiDi>
    <basicUdiDi>B-HB-5616-FGXJ</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>ADP MEA</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5616-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:34.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5614-FGX4</udiDi>
    <basicUdiDi>B-HB-5614-FGX4</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Collagen MEA</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5614-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:33.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5613-FGWV</udiDi>
    <basicUdiDi>B-HB-5613-FGWV</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Acetylsalicylic Acid MEA</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5613-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:32.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5548-FGYL</udiDi>
    <basicUdiDi>B-HB-5548-FGYL</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>U46619 (100uM) 1x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020404</emdnCode>
    <emdnDescription>THROMBOXANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5548-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:28.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5533-FGX6</udiDi>
    <basicUdiDi>B-HB-5533-FGX6</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>TRAP-6 2x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5533-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:27.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5515-FGWW</udiDi>
    <basicUdiDi>B-HB-5515-FGWW</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Prostaglandin E1 1x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020403</emdnCode>
    <emdnDescription>PROSTACYCLIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5515-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:26.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5514-FGWP</udiDi>
    <basicUdiDi>B-HB-5514-FGWP</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Acetylsalicylic Acid 1x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5514-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:26.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5511-FGW2</udiDi>
    <basicUdiDi>B-HB-5511-FGW2</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Epinephrine 2x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5511-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:22.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5506-FGWS</udiDi>
    <basicUdiDi>B-HB-5506-FGWS</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Arachidonic Acid 2x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5506-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:19.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5504-FGWC</udiDi>
    <basicUdiDi>B-HB-5504-FGWC</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>Collagen 2x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5504-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:15.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HB-5502-FGVW</udiDi>
    <basicUdiDi>B-HB-5502-FGVW</basicUdiDi>
    <tradeName>Hart Biologicals</tradeName>
    <deviceName>ADP 2x1ml</deviceName>
    <manufacturerName>Hart Biologicals Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000029121</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed UK Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000023135</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-5502-FG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:14.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450869269</udiDi>
    <basicUdiDi>B-13607450869269</basicUdiDi>
    <tradeName>TRAP-6</tradeName>
    <deviceName>TRAP-6</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86926</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:22.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450869252</udiDi>
    <basicUdiDi>B-13607450869252</basicUdiDi>
    <tradeName>Epinephrine</tradeName>
    <deviceName>Epinephrine</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020401</emdnCode>
    <emdnDescription>AGGREGATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86925</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:21.503Z</lastUpdated>
  </row>
</eudamedExport>