<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>00861900000374</udiDi>
    <basicUdiDi>B-00861900000374</basicUdiDi>
    <tradeName>Coag-Sense Prothrombin Time (PT) /INR Monitoring System</tradeName>
    <deviceName>Coag-Sense Prothrombin Time (PT)/INR Monitoring System Professional Use</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>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03P70-02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:24.601Z</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>
</eudamedExport>