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    <tradeName>ACL TOP 550 CTS</tradeName>
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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:08.282Z</lastUpdated>
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    <tradeName>Sample Rack Set 85-96, ACL CTS</tradeName>
    <deviceName>Sample Rack Set 85-96, ACL CTS</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <tradeName>Sample Rack Set 73-84, ACL CTS</tradeName>
    <deviceName>Sample Rack Set 73-84, ACL CTS</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
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    <tradeName>Sample Rack Set 49-60, ACL CTS</tradeName>
    <deviceName>Sample Rack Set 49-60, ACL CTS</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>00029400905</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:02.669Z</lastUpdated>
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    <udiDi>08426950717072</udiDi>
    <basicUdiDi>84269507170728A</basicUdiDi>
    <tradeName>Sample Rack Set 33-40, ACL TOP</tradeName>
    <deviceName>Sample Rack Set 33-40, ACL TOP</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020180</emdnCode>
    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00029400545</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:01.072Z</lastUpdated>
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    <udiDi>08426950717065</udiDi>
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    <tradeName>Sample Rack Set 25-32, ACL TOP</tradeName>
    <deviceName>Sample Rack Set 25-32, ACL TOP</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>00029400544</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>Sample Rack Set 17-24, ACL TOP</tradeName>
    <deviceName>Sample Rack Set 17-24, ACL TOP</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00029400543</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:56.774Z</lastUpdated>
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    <tradeName>CTS Rack Adapter blue (96 PK)</tradeName>
    <deviceName>CTS Rack Adapter blue (96 PK)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00027500149</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:55.469Z</lastUpdated>
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    <udiDi>08426950716884</udiDi>
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    <tradeName>CTS Rack Adapter blue (48 PK)</tradeName>
    <deviceName>CTS Rack Adapter blue (48 PK)</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>00027500148</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:54.672Z</lastUpdated>
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    <udiDi>08426950716440</udiDi>
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    <tradeName>Sarstedt rack set 14mm 09-16, ACL CTS</tradeName>
    <deviceName>Sarstedt rack set 14mm 09-16, ACL CTS</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>00000051402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:54.125Z</lastUpdated>
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    <udiDi>08426950716433</udiDi>
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    <tradeName>Sarstedt rack set 14mm 01-08, ACL CTS</tradeName>
    <deviceName>Sarstedt rack set 14mm 01-08, ACL CTS</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>00000051401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:49.870Z</lastUpdated>
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    <udiDi>08426950639817</udiDi>
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    <tradeName>Cuvette, Waste Bin, 10/package</tradeName>
    <deviceName>Cuvette, Waste Bin, 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>00027344900</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:41.863Z</lastUpdated>
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    <udiDi>08426950602422</udiDi>
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    <tradeName>HemosIL AcuStar ADAMTS13 Activity</tradeName>
    <deviceName>HemosIL AcuStar ADAMTS13 Activity</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>W0103020311</emdnCode>
    <emdnDescription>ADAMTS13 (ACTIVITY, AG, AB, INHIBITOR) SPECIFIC VON WILLEBRAND FACTOR (VWF) - CLEAVING PROTEASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802048</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:37.064Z</lastUpdated>
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    <tradeName>HemosIL AcuStar Cleaning Solution</tradeName>
    <deviceName>HemosIL AcuStar Cleaning Solution</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>0009802204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:36.256Z</lastUpdated>
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    <tradeName>HemosIL AcuStar VWF Controls</tradeName>
    <deviceName>HemosIL AcuStar VWF 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802119</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:17.790Z</lastUpdated>
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    <tradeName>HemosIL AcuStar VWF:RCo</tradeName>
    <deviceName>HemosIL AcuStar VWF:RCo</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>W0103020217</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND ACTIVITY / RISTOCETIN COFACTOR ACTIVITY (RCO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:17.011Z</lastUpdated>
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    <tradeName>HemosIL AcuStar VWF:Ag</tradeName>
    <deviceName>HemosIL AcuStar VWF:Ag</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <emdnCode>W0103020215</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND (AG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:16.197Z</lastUpdated>
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    <tradeName>HemosIL AcuStar Multi-Ab Controls</tradeName>
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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00009800003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:11.386Z</lastUpdated>
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    <tradeName>Kit Replacement Piercing Probe CTS</tradeName>
    <deviceName>Kit Replacement Piercing Probe CTS</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020180</emdnCode>
    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00028600006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:10.586Z</lastUpdated>
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    <tradeName>10 mL Vial Reagent Adapter without magnetic stirring (pink), 4/package</tradeName>
    <deviceName>10 mL Vial Reagent Adapter without magnetic stirring (pink), 4/package</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020180</emdnCode>
    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00019076200</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:09.808Z</lastUpdated>
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