<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03610230008355</udiDi>
    <basicUdiDi>B-03610230008355</basicUdiDi>
    <tradeName>Yumizen G APTT 4</tradeName>
    <deviceName>Yumizen G APTT 4</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036377</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:49.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008348</udiDi>
    <basicUdiDi>B-03610230008348</basicUdiDi>
    <tradeName>Yumizen G PT Reco 10</tradeName>
    <deviceName>Yumizen G PT Reco 10</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036376</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:45.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008331</udiDi>
    <basicUdiDi>B-03610230008331</basicUdiDi>
    <tradeName>Yumizen G PT Liq 4</tradeName>
    <deviceName>Yumizen G PT Liq 4</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036373</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:44.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008324</udiDi>
    <basicUdiDi>B-03610230008324</basicUdiDi>
    <tradeName>Yumizen G PT 5</tradeName>
    <deviceName>Yumizen G PT 5</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036338</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:43.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607450008470</udiDi>
    <basicUdiDi>B-03607450008470</basicUdiDi>
    <tradeName>C.K. Prest® 5</tradeName>
    <deviceName>C.K. Prest® 5</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00847</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:25.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607450005981</udiDi>
    <basicUdiDi>B-03607450005981</basicUdiDi>
    <tradeName>C.K. Prest® 2</tradeName>
    <deviceName>C.K. Prest® 2</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00598</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:12.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>00861900000398</udiDi>
    <basicUdiDi>B-00861900000398</basicUdiDi>
    <tradeName>Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit</tradeName>
    <deviceName>Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit - 50 Count</deviceName>
    <manufacturerName>CoaguSense Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026989</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03P56-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:25.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040656138</udiDi>
    <basicUdiDi>B-00850040656138</basicUdiDi>
    <tradeName>Coag-Sense Control Test Strip Kit - 10 Count</tradeName>
    <deviceName>Coag-Sense Control Test Strip Kit - 10 Count</deviceName>
    <manufacturerName>CoaguSense Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026989</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03P69-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:42.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040656091</udiDi>
    <basicUdiDi>B-00850040656091</basicUdiDi>
    <tradeName>Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit</tradeName>
    <deviceName>Coag-Sense Prothrombin Time (PT)/INR Test Strip, 50 Count</deviceName>
    <manufacturerName>CoaguSense Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026989</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03P57-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:41.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850032840200</udiDi>
    <basicUdiDi>B-00850032840200</basicUdiDi>
    <tradeName>Perosphere ClotChek</tradeName>
    <deviceName>Perosphere ClotChek, OUS</deviceName>
    <manufacturerName>Perosphere Technologies Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000048660</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:01.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850032840040</udiDi>
    <basicUdiDi>B-00850032840040</basicUdiDi>
    <tradeName>ClotChek Cuvettes (20 Pack), Global</tradeName>
    <deviceName>Perosphere ClotChek Cuvettes (20 Pack)</deviceName>
    <manufacturerName>Perosphere Technologies Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000048660</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:59.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845275000665</udiDi>
    <basicUdiDi>B-00845275000665</basicUdiDi>
    <tradeName>00845275000665</tradeName>
    <deviceName>Pacific Hemostasis APTT-XL</deviceName>
    <manufacturerName>Fisher Diagnostics A division of Fisher Scientific Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029041</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100403, J100403</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:50.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845275000641</udiDi>
    <basicUdiDi>B-00845275000641</basicUdiDi>
    <tradeName>00845275000641</tradeName>
    <deviceName>Pacific Hemostasis® APTT-XL</deviceName>
    <manufacturerName>Fisher Diagnostics A division of Fisher Scientific Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029041</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100402, J100402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:46.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845275000573</udiDi>
    <basicUdiDi>B-00845275000573</basicUdiDi>
    <tradeName>00845275000573</tradeName>
    <deviceName>Pacific Hemostasis® Coagulation Control Plasmas, Level 3</deviceName>
    <manufacturerName>Fisher Diagnostics A division of Fisher Scientific Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029041</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100597, J100597</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:44.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845275000542</udiDi>
    <basicUdiDi>B-00845275000542</basicUdiDi>
    <tradeName>00845275000542</tradeName>
    <deviceName>Pacific Hemostasis Thromboplastin-D</deviceName>
    <manufacturerName>Fisher Diagnostics A division of Fisher Scientific Company, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029041</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100356</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:43.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640175460112</udiDi>
    <basicUdiDi>76401754609134867190VM</basicUdiDi>
    <tradeName>07640175460112</tradeName>
    <deviceName>Batroxobin Time</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09134867190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:39:51.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350060320127</udiDi>
    <basicUdiDi>7350060320056U</basicUdiDi>
    <tradeName>MRX APTT</tradeName>
    <deviceName>APTT</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5029</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:02:13.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350060320073</udiDi>
    <basicUdiDi>7350060320036Q</basicUdiDi>
    <tradeName>MRX PT Owren</tradeName>
    <deviceName>PT Owren</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5026</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:02:12.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978507780241</udiDi>
    <basicUdiDi>697850778BCA10L5</basicUdiDi>
    <tradeName>Coagulation Analyzer</tradeName>
    <deviceName>Coagulation Analyzer</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048840</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN0126</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:37:39.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802615485</udiDi>
    <basicUdiDi>69268026MD78C000000000134</basicUdiDi>
    <tradeName>06926802615485</tradeName>
    <deviceName>Heparin Assay</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01401E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:41:48.314Z</lastUpdated>
  </row>
</eudamedExport>