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    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>00029400542</reference>
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    <lastUpdated>2026-07-03T10:07:42.217Z</lastUpdated>
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    <tradeName>Sample Rack Set 09-16, ACL CTS</tradeName>
    <deviceName>Sample Rack Set 09-16, ACL CTS</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
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    <tradeName>Kit, Adapter 4mL Vial ACL TOP</tradeName>
    <deviceName>Kit, Adapter 4mL Vial ACL TOP</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
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    <tradeName>Adapter, Diluent 4mL,Rack Adapter, 2 pcs</tradeName>
    <deviceName>Adapter, Diluent 4mL,Rack Adapter, 2 pcs</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>00028526001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:25.356Z</lastUpdated>
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    <udiDi>08426950569213</udiDi>
    <basicUdiDi>84269505692139F</basicUdiDi>
    <tradeName>Sample Rack Set 57-64, ACL TOP</tradeName>
    <deviceName>Sample Rack Set 57-64, 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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>00029400548</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:21.355Z</lastUpdated>
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    <basicUdiDi>842695056902296</basicUdiDi>
    <tradeName>Sample Rack Set 49-56, ACL TOP</tradeName>
    <deviceName>Sample Rack Set 49-56, 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>
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    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00029400547</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:20.549Z</lastUpdated>
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    <udiDi>08426950568940</udiDi>
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    <tradeName>Air Filter Assay</tradeName>
    <deviceName>Air Filter Assay</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>00018181271</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:19.750Z</lastUpdated>
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    <tradeName>Sample Rack Set 13-24, ACL CTS</tradeName>
    <deviceName>Sample Rack Set 13-24, ACL 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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>00029400902</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:18.956Z</lastUpdated>
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    <udiDi>08426950568889</udiDi>
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    <tradeName>Syringes and plunger Assy (250 uL)</tradeName>
    <deviceName>Syringes and plunger Assy (250 uL)</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>00028754001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:14.956Z</lastUpdated>
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    <udiDi>08426950568872</udiDi>
    <basicUdiDi>8426950568872AN</basicUdiDi>
    <tradeName>Assy, Needle, ACL Elite/Elite Pro</tradeName>
    <deviceName>Assy, Needle, ACL Elite/Elite Pro</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>00018110843</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:14.150Z</lastUpdated>
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    <udiDi>08426950568674</udiDi>
    <basicUdiDi>8426950568674AG</basicUdiDi>
    <tradeName>Sample Tube Adapter CTS 10/PK</tradeName>
    <deviceName>Sample Tube Adapter CTS 10/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>00028533600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:13.367Z</lastUpdated>
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    <udiDi>08426950568582</udiDi>
    <basicUdiDi>8426950568582AA</basicUdiDi>
    <tradeName>ACL TOP 700 750 Filter reagent cooling fan</tradeName>
    <deviceName>ACL TOP 700 750 Filter reagent cooling fan</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>00028617301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:12.551Z</lastUpdated>
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    <basicUdiDi>84269505685519X</basicUdiDi>
    <tradeName>Kit, Adapter 10mL Vial ACL TOP</tradeName>
    <deviceName>Kit, Adapter 10mL Vial 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>00028520901</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:08.545Z</lastUpdated>
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    <udiDi>08426950568438</udiDi>
    <basicUdiDi>8426950568438A2</basicUdiDi>
    <tradeName>Pump/Probe Tubing Assembly</tradeName>
    <deviceName>Pump/Probe Tubing Assembly</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>00028741600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:07.741Z</lastUpdated>
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    <tradeName>2D Bar Code Reader Upgrade Kit</tradeName>
    <deviceName>2D Bar Code Reader Upgrade Kit</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>00028210500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:06.944Z</lastUpdated>
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    <tradeName>Tray, 6 Sample Rack, Holder</tradeName>
    <deviceName>Tray, 6 Sample Rack, Holder</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <emdnCode>W0202020180</emdnCode>
    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00028780201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:06.140Z</lastUpdated>
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    <udiDi>08426950567998</udiDi>
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    <tradeName>Micro Tube Adapter 10/PK</tradeName>
    <deviceName>Micro Tube Adapter 10/PK</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
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    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:02.138Z</lastUpdated>
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    <tradeName>Clean, Aspirator Assy (Tube connecting ACL TOP instrument to the Clean Bottle)</tradeName>
    <deviceName>Clean, Aspirator Assy (Tube connecting ACL TOP instrument to the Clean Bottle)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
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    <emdnDescription>COAGULOMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00028713200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:01.340Z</lastUpdated>
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    <tradeName>Reagent Rack Set, RA - RD</tradeName>
    <deviceName>Reagent Rack Set, RA - RD</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>00029400641</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:07:00.534Z</lastUpdated>
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    <tradeName>Sample Rack Set 41-48, ACL TOP</tradeName>
    <deviceName>Sample Rack Set 41-48, 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>00029400546</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:59.740Z</lastUpdated>
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