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<eudamedExport entity="devices">
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    <basicUdiDi>84269500624246C</basicUdiDi>
    <tradeName>HemosIL Factor V Leiden (APC Resistance V)</tradeName>
    <deviceName>HemosIL Factor V Leiden (APC Resistance V)</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>W0103020610</emdnCode>
    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020008700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:45.047Z</lastUpdated>
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    <udiDi>08426950062295</udiDi>
    <basicUdiDi>84269500622956R</basicUdiDi>
    <tradeName>HemosIL Factor Diluent</tradeName>
    <deviceName>HemosIL Factor Diluent</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009757600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:44.242Z</lastUpdated>
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    <udiDi>08426950057949</udiDi>
    <basicUdiDi>84269500579498D</basicUdiDi>
    <tradeName>Sample Cups, 0.5 mL, 1000/package</tradeName>
    <deviceName>Sample Cups, 0.5 mL, 1000/package</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00006799200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:43.442Z</lastUpdated>
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    <udiDi>08426950056812</udiDi>
    <basicUdiDi>84269500568127A</basicUdiDi>
    <tradeName>Sample Tray Adapter for Plastic Cups, 4/package</tradeName>
    <deviceName>Sample Tray Adapter for Plastic Cups, 4/package</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020180</emdnCode>
    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00019076400</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:42.648Z</lastUpdated>
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    <udiDi>08426950056003</udiDi>
    <basicUdiDi>84269500560035Z</basicUdiDi>
    <tradeName>HemosIL Liquid Antithrombin</tradeName>
    <deviceName>HemosIL Liquid Antithrombin</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>W0103020602</emdnCode>
    <emdnDescription>ANTITHROMBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020002500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:37.842Z</lastUpdated>
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    <udiDi>08426950055990</udiDi>
    <basicUdiDi>84269500559907U</basicUdiDi>
    <tradeName>HemosIL Cleaning Solution (Clean A)</tradeName>
    <deviceName>HemosIL Cleaning Solution (Clean A)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009831700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:37.428Z</lastUpdated>
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    <udiDi>08426950048466</udiDi>
    <basicUdiDi>84269500484667G</basicUdiDi>
    <tradeName>Magnetic Stirrer Bars, 6 per package</tradeName>
    <deviceName>Magnetic Stirrer Bars, 6 per package</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00009746606</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:19.370Z</lastUpdated>
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    <udiDi>08426950043966</udiDi>
    <basicUdiDi>842695004396676</basicUdiDi>
    <tradeName>HemosIL ProClot diluent</tradeName>
    <deviceName>HemosIL ProClot diluent</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020607</emdnCode>
    <emdnDescription>PROTEIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0008468600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:18.563Z</lastUpdated>
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  <row>
    <udiDi>08426950041177</udiDi>
    <basicUdiDi>84269500411775M</basicUdiDi>
    <tradeName>HemosIL von Willebrand Factor Antigen</tradeName>
    <deviceName>HemosIL von Willebrand Factor Antigen</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>W0103020215</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND (AG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020002300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:16.977Z</lastUpdated>
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  <row>
    <udiDi>08426950038733</udiDi>
    <basicUdiDi>842695003873375</basicUdiDi>
    <tradeName>Sample Cups, 4 mL, 100/package</tradeName>
    <deviceName>Sample Cups, 4 mL, 100/package</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00006799400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:14.568Z</lastUpdated>
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    <udiDi>08426950031734</udiDi>
    <basicUdiDi>84269500317345N</basicUdiDi>
    <tradeName>HemosIL Plasmin Inhibitor</tradeName>
    <deviceName>HemosIL Plasmin Inhibitor</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>W0103020501</emdnCode>
    <emdnDescription>A2-ANTIPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020009200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:05.758Z</lastUpdated>
  </row>
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    <udiDi>08426950026549</udiDi>
    <basicUdiDi>84269500265496H</basicUdiDi>
    <tradeName>HemosIL Cleaning Agent (Clean B)</tradeName>
    <deviceName>HemosIL Cleaning Agent (Clean B)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009832700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:03.368Z</lastUpdated>
  </row>
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    <udiDi>08426950026525</udiDi>
    <basicUdiDi>842695002652563</basicUdiDi>
    <tradeName>Sample and Reagent Tubing, 1.5 meters long</tradeName>
    <deviceName>Sample and Reagent Tubing, 1.5 meters long</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020180</emdnCode>
    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00007328901</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:01.061Z</lastUpdated>
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    <udiDi>08426950003274</udiDi>
    <basicUdiDi>84269500032744N</basicUdiDi>
    <tradeName>HemosIL ProClot</tradeName>
    <deviceName>HemosIL ProClot</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>W0103020607</emdnCode>
    <emdnDescription>PROTEIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0008468310</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:44.143Z</lastUpdated>
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    <udiDi>08426950003151</udiDi>
    <basicUdiDi>842695000315145</basicUdiDi>
    <tradeName>08426950003151</tradeName>
    <deviceName>Rotors, 20 cuvettes, 100/package</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00006800000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:42.592Z</lastUpdated>
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    <udiDi>08426950866879</udiDi>
    <basicUdiDi>8426950866879BV</basicUdiDi>
    <tradeName>HemosIL Apixaban Controls</tradeName>
    <deviceName>HemosIL Apixaban Controls</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020014300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:28.824Z</lastUpdated>
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    <udiDi>08426950866862</udiDi>
    <basicUdiDi>8426950866862BC</basicUdiDi>
    <tradeName>HemosIL Apixaban Calibrators</tradeName>
    <deviceName>HemosIL Apixaban Calibrators</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020014200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:27.625Z</lastUpdated>
  </row>
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    <udiDi>08426950808855</udiDi>
    <basicUdiDi>84269508088559T</basicUdiDi>
    <tradeName>HemosIL Liquid Anti-Xa</tradeName>
    <deviceName>HemosIL Liquid Anti-Xa</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020309</emdnCode>
    <emdnDescription>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00020302601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:26.437Z</lastUpdated>
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    <udiDi>08426950632894</udiDi>
    <basicUdiDi>842695063289492</basicUdiDi>
    <tradeName>HemosIL Direct Thrombin Inhibitor Assay</tradeName>
    <deviceName>HemosIL Direct Thrombin Inhibitor Assay</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020310</emdnCode>
    <emdnDescription>ANTI IIA ACTIVITY FOT DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020302800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:25.214Z</lastUpdated>
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    <udiDi>08426950632887</udiDi>
    <basicUdiDi>842695063288795</basicUdiDi>
    <tradeName>HemosIL ReadiPlasTin</tradeName>
    <deviceName>HemosIL ReadiPlasTin</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:19.210Z</lastUpdated>
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