<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04262353370049</udiDi>
    <basicUdiDi>B-04262353370049</basicUdiDi>
    <tradeName>PoET HBV</tradeName>
    <deviceName>PoET HBV</deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2B-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:54:18.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370162</udiDi>
    <basicUdiDi>42623533727MF</basicUdiDi>
    <tradeName>PoET Instrument</tradeName>
    <deviceName>PoET Instrument</deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P9A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:26:11.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370018</udiDi>
    <basicUdiDi>42623533712M2</basicUdiDi>
    <tradeName>PoET Prep Reagent</tradeName>
    <deviceName>PoET Prep Reagent</deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1B-24-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:26:10.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370001</udiDi>
    <basicUdiDi>42623533711LY</basicUdiDi>
    <tradeName>PoET Extraction</tradeName>
    <deviceName>PoET Extraction</deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1A-24-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:26:10.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370209</udiDi>
    <basicUdiDi>B-04262353370209</basicUdiDi>
    <tradeName>PoET Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3A-500-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:28.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370193</udiDi>
    <basicUdiDi>B-04262353370193</basicUdiDi>
    <tradeName>PoET Internal Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1C-1440-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:27.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370155</udiDi>
    <basicUdiDi>B-04262353370155</basicUdiDi>
    <tradeName>PoET WNV Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3H-180-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:25.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370131</udiDi>
    <basicUdiDi>B-04262353370131</basicUdiDi>
    <tradeName>PoET HEV Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3F-180-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:25.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370124</udiDi>
    <basicUdiDi>B-04262353370124</basicUdiDi>
    <tradeName>PoET Master Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3B-360-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:24.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370100</udiDi>
    <basicUdiDi>B-04262353370100</basicUdiDi>
    <tradeName>PoET WNV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040526</emdnCode>
    <emdnDescription>WEST NILE VIRUS - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2H-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:23.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370087</udiDi>
    <basicUdiDi>B-04262353370087</basicUdiDi>
    <tradeName>PoET HEV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2F-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:22.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370070</udiDi>
    <basicUdiDi>B-04262353370070</basicUdiDi>
    <tradeName>PoET B19V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040509</emdnCode>
    <emdnDescription>PARVOVIRUS B 19 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2E-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:21.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370063</udiDi>
    <basicUdiDi>B-04262353370063</basicUdiDi>
    <tradeName>PoET HAV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2D-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:20.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370056</udiDi>
    <basicUdiDi>B-04262353370056</basicUdiDi>
    <tradeName>PoET HIV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105030405</emdnCode>
    <emdnDescription>HIV MULTIPLE - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2C-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:19.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370032</udiDi>
    <basicUdiDi>B-04262353370032</basicUdiDi>
    <tradeName>PoET HCV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2A-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:12.685Z</lastUpdated>
  </row>
</eudamedExport>