<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08426950441335</udiDi>
    <basicUdiDi>842695044133573</basicUdiDi>
    <tradeName>Sample Cups 2.0 mL, 1000/package</tradeName>
    <deviceName>Sample Cups 2.0 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>0005575100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:04:22.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950088226</udiDi>
    <basicUdiDi>842695008822686</basicUdiDi>
    <tradeName>Cuvette Waste Liner, 10/package</tradeName>
    <deviceName>Cuvette Waste Liner, 10/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>00029401100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:04:05.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950078944</udiDi>
    <basicUdiDi>84269500789448Y</basicUdiDi>
    <tradeName>HemosIL Wash-R Emulsion</tradeName>
    <deviceName>HemosIL Wash-R Emulsion</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>0020002400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:51.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950075899</udiDi>
    <basicUdiDi>84269500758998X</basicUdiDi>
    <tradeName>ACL TOP Cuvettes</tradeName>
    <deviceName>ACL TOP Cuvettes</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>0029400100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:50.740Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>08057920560031</udiDi>
    <basicUdiDi>805792056Diamond4GF</basicUdiDi>
    <tradeName>DIAMOND 4</tradeName>
    <deviceName>DIAMOND 4</deviceName>
    <manufacturerName>Tridema Engineering srl</manufacturerName>
    <manufacturerSrn>IT-MF-000054318</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIAM2026</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:52:38.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920560024</udiDi>
    <basicUdiDi>805792056Diamond2GB</basicUdiDi>
    <tradeName>DIAMOND 2</tradeName>
    <deviceName>Diamond 2</deviceName>
    <manufacturerName>Tridema Engineering srl</manufacturerName>
    <manufacturerSrn>IT-MF-000054318</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIAM2014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:52:21.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920560000</udiDi>
    <basicUdiDi>805792056DiamondQN</basicUdiDi>
    <tradeName>Diamond</tradeName>
    <deviceName>Diamond</deviceName>
    <manufacturerName>Tridema Engineering srl</manufacturerName>
    <manufacturerSrn>IT-MF-000054318</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIAM2010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:52:16.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055002199940</udiDi>
    <basicUdiDi>8055002190S04YR</basicUdiDi>
    <tradeName>SCLAVO CLOT 4</tradeName>
    <deviceName>SCLAVO CLOT 4</deviceName>
    <manufacturerName>Sclavo Diagnostics International S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000030694</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K27401004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:15:53.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033675433486</udiDi>
    <basicUdiDi>803367543SQV7</basicUdiDi>
    <tradeName>SOLEA QUICK - COAGULOMETER 1 CHANNEL, including accessories</tradeName>
    <deviceName>SOLEA QUICK</deviceName>
    <manufacturerName>BPC Biosed Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000032961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SOLEA QUICK</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:09:54.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>015400</udiDi>
    <basicUdiDi>++EUBECOASETRCSD</basicUdiDi>
    <tradeName>Thrombo C4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kommanditgesellschaft Behnk Elektronik GmbH &amp; Co.</manufacturerName>
    <manufacturerSrn>DE-MF-000005304</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>015400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:33:24.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975237551080</udiDi>
    <basicUdiDi>697523755SC46</basicUdiDi>
    <tradeName>06975237551080</tradeName>
    <deviceName>Semi Automatic Coagulation Analyzer</deviceName>
    <manufacturerName>TAIZHOU STEELLEX BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023056</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>SC20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:25.039Z</lastUpdated>
  </row>
</eudamedExport>