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<eudamedExport entity="devices">
  <row>
    <udiDi>04719878570435</udiDi>
    <basicUdiDi>B-04719878570435</basicUdiDi>
    <tradeName>VitaPCR Flu A&amp;B External Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0136</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:33:24.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719878570428</udiDi>
    <basicUdiDi>B-04719878570428</basicUdiDi>
    <tradeName>VitaPCR SARS-CoV-2 Gen 2 External Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0135</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:33:23.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719878570176</udiDi>
    <basicUdiDi>B-04719878570176</basicUdiDi>
    <tradeName>VitaPCR SARS-CoV-2 External Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0115</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:33:21.028Z</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>03760369292122</udiDi>
    <basicUdiDi>376036929DGV0019K</basicUdiDi>
    <tradeName>NatQal HCV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>190001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:10:50.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760369291217</udiDi>
    <basicUdiDi>376036929SMI001EV</basicUdiDi>
    <tradeName>SeroQal ARCHI 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>252202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:08:14.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414592220</udiDi>
    <basicUdiDi>0405686901507VH</basicUdiDi>
    <tradeName>ADVIA Centaur Quantitative HBsAg (QHBs) Quality Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10699088</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:04:24.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000026</udiDi>
    <basicUdiDi>754022452766AY</basicUdiDi>
    <tradeName>REDx HPV 18 Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-62-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000064</udiDi>
    <basicUdiDi>754022452766AY</basicUdiDi>
    <tradeName>REDx HPV 45 Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-62-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000224</udiDi>
    <basicUdiDi>754022464748BP</basicUdiDi>
    <tradeName>REDxFLOQ SARS-CoV-2 Swab Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-S-19-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000286</udiDi>
    <basicUdiDi>754022464748BP</basicUdiDi>
    <tradeName>REDx SARS-CoV-2 Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-99-M3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000293</udiDi>
    <basicUdiDi>754022464748BP</basicUdiDi>
    <tradeName>REDxFLOQ SARS-CoV-2 Swab Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-S-99-M4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000316</udiDi>
    <basicUdiDi>754022464922BF</basicUdiDi>
    <tradeName>REDxFLOQ SARS-CoV-2 Ag Swab Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-S-19-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670170</udiDi>
    <basicUdiDi>426046567SRBlueSF</basicUdiDi>
    <tradeName>Optitrol Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:32.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670187</udiDi>
    <basicUdiDi>426046567SRBlueSF</basicUdiDi>
    <tradeName>Optitrol Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:32.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670200</udiDi>
    <basicUdiDi>426046567SRYellow8D</basicUdiDi>
    <tradeName>Optitrol Yellow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:32.054Z</lastUpdated>
  </row>
</eudamedExport>