<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>00850032840088</udiDi>
    <basicUdiDi>B-00850032840088</basicUdiDi>
    <tradeName>ClotChek Liquid Quality Controls Kit, Global</tradeName>
    <deviceName>ClotChek Liquid Quality Controls Kit, Global</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>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:00.751Z</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>
</eudamedExport>