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<eudamedExport entity="devices">
  <row>
    <udiDi>05391521421982</udiDi>
    <basicUdiDi>53915214FD50HR</basicUdiDi>
    <tradeName>sthemA FD-50</tradeName>
    <deviceName>sthemA FD-50</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01471</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:37.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421999</udiDi>
    <basicUdiDi>53915214CL250AE</basicUdiDi>
    <tradeName>sthemA CL-250</tradeName>
    <deviceName>sthemA CL-250</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01424</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:35.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421890</udiDi>
    <basicUdiDi>53915214DL900069</basicUdiDi>
    <tradeName>sthemA DL-9000</tradeName>
    <deviceName>sthemA DL-9000</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01413</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:33.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421791</udiDi>
    <basicUdiDi>53915214FL50JZ</basicUdiDi>
    <tradeName>sthemA FL-50</tradeName>
    <deviceName>sthemA FL-50</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01422</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:33.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421821</udiDi>
    <basicUdiDi>53915214QUARKPM</basicUdiDi>
    <tradeName>sthemA 601</tradeName>
    <deviceName>sthemA 601</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</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>58878</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:31.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421814</udiDi>
    <basicUdiDi>53915214WB250F4</basicUdiDi>
    <tradeName>sthemA WB-250</tradeName>
    <deviceName>sthemA WB-250</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01408</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:30.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421807</udiDi>
    <basicUdiDi>53915214HB2509X</basicUdiDi>
    <tradeName>sthemA HB-250</tradeName>
    <deviceName>sthemA HB-250</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01405</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:29.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421784</udiDi>
    <basicUdiDi>53915214DL25005H</basicUdiDi>
    <tradeName>sthemA DL-2500</tradeName>
    <deviceName>sthemA DL-2500</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01412</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:16.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421777</udiDi>
    <basicUdiDi>53915214CL15JA</basicUdiDi>
    <tradeName>sthemA CL-15</tradeName>
    <deviceName>sthemA CL-15</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01423</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:15.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421722</udiDi>
    <basicUdiDi>53915214DTFW4</basicUdiDi>
    <tradeName>DT Fluid</tradeName>
    <deviceName>DT Fluid</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020999</emdnCode>
    <emdnDescription>AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTF</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:14.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421524</udiDi>
    <basicUdiDi>53915214CUVETTEUX</basicUdiDi>
    <tradeName>Macro Cuvettes with balls</tradeName>
    <deviceName>Macro cuvettes with balls</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z05100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:13.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421302</udiDi>
    <basicUdiDi>53915214DTWX6</basicUdiDi>
    <tradeName>DT Wash</tradeName>
    <deviceName>DT Wash</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020999</emdnCode>
    <emdnDescription>AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTW</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:12.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421210</udiDi>
    <basicUdiDi>53915214BUFOWKQ</basicUdiDi>
    <tradeName>TriniCLOT Owrens Buffer</tradeName>
    <deviceName>TriniCLOT Owrens Buffer</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1903</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:12.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421012</udiDi>
    <basicUdiDi>53915214KC4UJ</basicUdiDi>
    <tradeName>KC 4 Delta</tradeName>
    <deviceName>KC 4 Delta</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N04000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:11.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521420510</udiDi>
    <basicUdiDi>53915214CHLORHU</basicUdiDi>
    <tradeName>TriniCLOT Calcium Chloride 0.025M</tradeName>
    <deviceName>TriniCLOT Calcium Chloride 0.025M</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020901</emdnCode>
    <emdnDescription>CALCIUM CHLORIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1902</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:10.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521420503</udiDi>
    <basicUdiDi>53915214BUFIMJJ</basicUdiDi>
    <tradeName>TriniCLOT Imidazole Buffer</tradeName>
    <deviceName>TriniCLOT Imidazole Buffer</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1901</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:09.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421760</udiDi>
    <basicUdiDi>B-05391521421760</basicUdiDi>
    <tradeName>TriniCLOT aPTT S 5 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1212</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:37:06.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421500</udiDi>
    <basicUdiDi>B-05391521421500</basicUdiDi>
    <tradeName>TriniCHECK LIA Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T4306</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:37:03.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421494</udiDi>
    <basicUdiDi>B-05391521421494</basicUdiDi>
    <tradeName>TriniLIA D-Dimer II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T3104</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:37:02.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391521421234</udiDi>
    <basicUdiDi>B-05391521421234</basicUdiDi>
    <tradeName>DT 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H02000</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:37:00.695Z</lastUpdated>
  </row>
</eudamedExport>