<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05907514602537</udiDi>
    <basicUdiDi>B-05907514602537</basicUdiDi>
    <tradeName>ACCENT-300 AMYLASE</tradeName>
    <deviceName>AMYLASE</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-355</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:58:10.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602414</udiDi>
    <basicUdiDi>B-05907514602414</basicUdiDi>
    <tradeName>ACCENT-300 LDH</tradeName>
    <deviceName>LDH</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010120</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE P ( LDH - P --&gt; L )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-339</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:43.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602339</udiDi>
    <basicUdiDi>B-05907514602339</basicUdiDi>
    <tradeName>ACCENT-300 CK-MB</tradeName>
    <deviceName>CK-MB</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-327</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:30.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602292</udiDi>
    <basicUdiDi>B-05907514602292</basicUdiDi>
    <tradeName>ACCENT-300 GGT</tradeName>
    <deviceName>GGT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-324</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:28.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602285</udiDi>
    <basicUdiDi>B-05907514602285</basicUdiDi>
    <tradeName>ACCENT-300 CK</tradeName>
    <deviceName>CK</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-320</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:24.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602254</udiDi>
    <basicUdiDi>B-05907514602254</basicUdiDi>
    <tradeName>ACCENT-300 ALAT</tradeName>
    <deviceName>ALAT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-316</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:23.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602230</udiDi>
    <basicUdiDi>B-05907514602230</basicUdiDi>
    <tradeName>ACCENT-300 ASAT</tradeName>
    <deviceName>ASAT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-314</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:23.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602216</udiDi>
    <basicUdiDi>B-05907514602216</basicUdiDi>
    <tradeName>ACCENT-300 ALP</tradeName>
    <deviceName>ALP</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-312</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:22.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514602179</udiDi>
    <basicUdiDi>B-05907514602179</basicUdiDi>
    <tradeName>ACCENT-300 LIPASE</tradeName>
    <deviceName>LIPASE</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-309</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:17.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514600212</udiDi>
    <basicUdiDi>B-05907514600212</basicUdiDi>
    <tradeName>Neo-200 ALAT</tradeName>
    <deviceName>ALAT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-R0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:51:06.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514600199</udiDi>
    <basicUdiDi>B-05907514600199</basicUdiDi>
    <tradeName>Neo-200 ALP</tradeName>
    <deviceName>ALP</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-R0003</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:51:02.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514600182</udiDi>
    <basicUdiDi>B-05907514600182</basicUdiDi>
    <tradeName>Neo-200 AMYLASE</tradeName>
    <deviceName>AMYLASE</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-R0004</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:51:01.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514600175</udiDi>
    <basicUdiDi>B-05907514600175</basicUdiDi>
    <tradeName>Neo-200 ASAT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-R0007</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:50:49.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514600113</udiDi>
    <basicUdiDi>B-05907514600113</basicUdiDi>
    <tradeName>Neo-200 GGT</tradeName>
    <deviceName>GGT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-R0025</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:50:37.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514600083</udiDi>
    <basicUdiDi>B-05907514600083</basicUdiDi>
    <tradeName>Neo-200 LDH</tradeName>
    <deviceName>LDH</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010120</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE P ( LDH - P --&gt; L )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-R0035</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:50:32.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514600069</udiDi>
    <basicUdiDi>B-05907514600069</basicUdiDi>
    <tradeName>Neo-200 LIPASE</tradeName>
    <deviceName>LIPASE</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-R0037</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:50:30.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003908716</udiDi>
    <basicUdiDi>B-05430003908716</basicUdiDi>
    <tradeName>SEEKER® LSD Reagent Kit - IDUA|GAA|GBA|GLA</tradeName>
    <deviceName>SEEKER® LSD Reagent Kit - IDUA|GAA|GBA|GLA</deviceName>
    <manufacturerName>LaCAR MDx Technologies</manufacturerName>
    <manufacturerSrn>BE-MF-000001212</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2111</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:51:31.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003908075</udiDi>
    <basicUdiDi>B-05430003908075</basicUdiDi>
    <tradeName>NEONATAL G-6-PD Screening Fluo</tradeName>
    <deviceName>NEONATAL G-6-PD Screening Fluo</deviceName>
    <manufacturerName>LaCAR MDx Technologies</manufacturerName>
    <manufacturerSrn>BE-MF-000001212</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-ME-576</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:51:30.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003908068</udiDi>
    <basicUdiDi>B-05430003908068</basicUdiDi>
    <tradeName>NEONATAL MSUD Screening Fluo</tradeName>
    <deviceName>NEONATAL MSUD Screening Fluo</deviceName>
    <manufacturerName>LaCAR MDx Technologies</manufacturerName>
    <manufacturerSrn>BE-MF-000001212</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-MD-576</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:51:29.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003908044</udiDi>
    <basicUdiDi>B-05430003908044</basicUdiDi>
    <tradeName>NEONATAL T-GAL Screening Fluo</tradeName>
    <deviceName>NEONATAL T-GAL Screening Fluo</deviceName>
    <manufacturerName>LaCAR MDx Technologies</manufacturerName>
    <manufacturerSrn>BE-MF-000001212</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I-MB-576</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:51:25.805Z</lastUpdated>
  </row>
</eudamedExport>