<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414640549</udiDi>
    <basicUdiDi>0405686900875WA</basicUdiDi>
    <tradeName>LA 2 Confirmation Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_LA1/2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873861</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:41.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+G0561025161/ $$0100114XXXXXU*</udiDi>
    <basicUdiDi>++G0561025163W</basicUdiDi>
    <tradeName>Lupus Anticoagulant Confirmation Reagent (LACR)</tradeName>
    <deviceName>Lupus Anticoagulant Confirmation Reagent (LACR)</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102516</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:19:07.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450005995</udiDi>
    <basicUdiDi>B-13607450005995</basicUdiDi>
    <tradeName>PTT-LA</tradeName>
    <deviceName>PTT-LA</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00599</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:08.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>10859394006146</udiDi>
    <basicUdiDi>B-10859394006146</basicUdiDi>
    <tradeName>LupoTek KCT</tradeName>
    <deviceName>LupoTek KCT</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87-305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:04.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>10859394006115</udiDi>
    <basicUdiDi>B-10859394006115</basicUdiDi>
    <tradeName>LupoTek Correctin VL</tradeName>
    <deviceName>LupoTek Correctin VL</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:59.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>10859394006108</udiDi>
    <basicUdiDi>B-10859394006108</basicUdiDi>
    <tradeName>LupoTek Detectin VL</tradeName>
    <deviceName>LupoTek Detectin VL</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85-202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:58.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607450006001</udiDi>
    <basicUdiDi>B-03607450006001</basicUdiDi>
    <tradeName>Staclot® LA</tradeName>
    <deviceName>Staclot® LA</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:12.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950513711</udiDi>
    <basicUdiDi>842695051371173</basicUdiDi>
    <tradeName>HemosIL dRVVT Confirm</tradeName>
    <deviceName>HemosIL dRVVT Confirm</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>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:01.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950513704</udiDi>
    <basicUdiDi>842695051370476</basicUdiDi>
    <tradeName>HemosIL dRVVT Screen</tradeName>
    <deviceName>HemosIL dRVVT Screen</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>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:00.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950433491</udiDi>
    <basicUdiDi>84269504334917M</basicUdiDi>
    <tradeName>HemosIL Silica Clotting Time</tradeName>
    <deviceName>HemosIL Silica Clotting Time</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>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020004800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:04:17.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012399</udiDi>
    <basicUdiDi>360745099LA0005XM</basicUdiDi>
    <tradeName>sthemO dRVV confirm</tradeName>
    <deviceName>sthemO dRVV confirm</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01239</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:00:03.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012375</udiDi>
    <basicUdiDi>360745099LA0006XP</basicUdiDi>
    <tradeName>sthemO dRVV screen M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01237</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:00:02.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450003335</udiDi>
    <basicUdiDi>360745099LA0004XK</basicUdiDi>
    <tradeName>STA® - Staclot® dRVV Screen 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00333</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:58:59.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450003342</udiDi>
    <basicUdiDi>360745099LA0003XH</basicUdiDi>
    <tradeName>STA® - Staclot® dRVV Confirm</tradeName>
    <deviceName>STA® - Staclot® dRVV Confirm</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00334</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:58:57.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768007507</udiDi>
    <basicUdiDi>0405686900875WA</basicUdiDi>
    <tradeName>LA 2 Confirmation Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446064</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:45:33.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414640600</udiDi>
    <basicUdiDi>0405686900875WA</basicUdiDi>
    <tradeName>LA 1 Screening Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873860</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:45:18.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377306002</udiDi>
    <basicUdiDi>B-06941377306002</basicUdiDi>
    <tradeName>Lupus Anticoagulant Assay Kit (Coagulation Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0035-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:18:25.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377305999</udiDi>
    <basicUdiDi>B-06941377305999</basicUdiDi>
    <tradeName>Lupus Anticoagulant Assay Kit (Coagulation Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0035-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:18:24.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377305982</udiDi>
    <basicUdiDi>B-06941377305982</basicUdiDi>
    <tradeName>Lupus Anticoagulant Assay Kit (Coagulation Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0035-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:18:22.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377305975</udiDi>
    <basicUdiDi>B-06941377305975</basicUdiDi>
    <tradeName>Lupus Anticoagulant Assay Kit (Coagulation Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020606</emdnCode>
    <emdnDescription>LUPUS ANTICOAGULANT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0034-08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:18:20.509Z</lastUpdated>
  </row>
</eudamedExport>