<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05902643962200</udiDi>
    <basicUdiDi>59026439CBCH802BL</basicUdiDi>
    <tradeName>05902643962200</tradeName>
    <deviceName>BioPath (surowica kontrolna) 4x5 ml</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-802-0020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:29.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643962194</udiDi>
    <basicUdiDi>59026439CBCH801BJ</basicUdiDi>
    <tradeName>05902643962194</tradeName>
    <deviceName>BioNorm (surowica kontrolna) 4x5 ml</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-801-0020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:29.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643961654</udiDi>
    <basicUdiDi>59026439CBCH213AT</basicUdiDi>
    <tradeName>05902643961654</tradeName>
    <deviceName>Amylaza BM 100 / BM 200</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-213-0080</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:15.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643961548</udiDi>
    <basicUdiDi>59026439CBCH151AW</basicUdiDi>
    <tradeName>05902643961548</tradeName>
    <deviceName>CRP  turbilatex 50 ml</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-151-0050</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:14.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643961524</udiDi>
    <basicUdiDi>59026439CBCH150AU</basicUdiDi>
    <tradeName>05902643961524</tradeName>
    <deviceName>CRP immunoturbidymetryczne 50ml</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-150-0050</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:13.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643961227</udiDi>
    <basicUdiDi>59026439CBCH033AP</basicUdiDi>
    <tradeName>05902643961227</tradeName>
    <deviceName>Glukoza BM 100 / BM 200</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-033-0400</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:12.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643961128</udiDi>
    <basicUdiDi>59026439CBCH018AT</basicUdiDi>
    <tradeName>05902643961128</tradeName>
    <deviceName>Bilirubina bezp. BM 100 / BM 200</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-018-0060</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:12.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643961111</udiDi>
    <basicUdiDi>59026439CBCH014AK</basicUdiDi>
    <tradeName>05902643961111</tradeName>
    <deviceName>Bilirubina całkowita DMSO 3x100 ml</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-014-0310</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:11.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643961081</udiDi>
    <basicUdiDi>59026439CBCH013AH</basicUdiDi>
    <tradeName>05902643961081</tradeName>
    <deviceName>Bilirubina całk. BM 100 / BM 200</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-013-0150</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:10.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959248</udiDi>
    <basicUdiDi>59026439BRT306JG</basicUdiDi>
    <tradeName>05902643959248</tradeName>
    <deviceName>Norovirus/ Rotavirus/ Adenovirus Combo 10 tests / INRA-635</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-306-K010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:09.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959231</udiDi>
    <basicUdiDi>59026439BRTDOA1740567S</basicUdiDi>
    <tradeName>05902643959231</tradeName>
    <deviceName>Multi-Drug 7 Panel 25 tests (MDPV/ ABP/ PVP/ FYL/ MEP/ K2/ CAT) / 1-DOA-174 056</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DOA-174 056</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:08.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959224</udiDi>
    <basicUdiDi>59026439BRTDOA16500473</basicUdiDi>
    <tradeName>05902643959224</tradeName>
    <deviceName>Multi-Drug 6 Cassette 25 tests (COC300/THC50/MTD300/MOP300/BZO300/AMP1000) 1-DOA-165 004</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DOA-165 004</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:08.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959217</udiDi>
    <basicUdiDi>59026439BRTDOA16411576</basicUdiDi>
    <tradeName>05902643959217</tradeName>
    <deviceName>Multi-Drug 6 Panel 25 tests (K2/ MDPV/ LSD/ OXY/ Mep/ CAT) / 1-DOA-164 115</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DOA-164 115</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:07.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959200</udiDi>
    <basicUdiDi>59026439BRTDOA1125012T5</basicUdiDi>
    <tradeName>05902643959200</tradeName>
    <deviceName>Multi-Drug 12 Cassette 25 tests (MET/ COC/ THC/ MDMA/ MTD/ MOP/ PCP/ BZO/ AMP/ TCA/ BAR/ OPI) / 1-DOA-1125 012</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DOA-1125 012</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:06.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959194</udiDi>
    <basicUdiDi>59026439BRTDOA1124028TD</basicUdiDi>
    <tradeName>05902643959194</tradeName>
    <deviceName>Multi-Drug 12 Panel 25 tests (OPI /MDMA/ MTD/ BZO/ AMP/ MET/ K2/ FYL/ THC/ BUP/ MEP/ CAT) / 1-DOA-1124 028</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DOA-1124 028</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:05.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959187</udiDi>
    <basicUdiDi>59026439BRTDOA1105012SF</basicUdiDi>
    <tradeName>05902643959187</tradeName>
    <deviceName>Multi-Drug 10 Cassette 25 tests MET/COC/THC/MDMA/MTD/AMP/MOP/BZO/TCA/BAR / 1-DOA-1105 012</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DOA-1105 012</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:05.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959163</udiDi>
    <basicUdiDi>59026439BRTDMEQG</basicUdiDi>
    <tradeName>05902643959163</tradeName>
    <deviceName>Methamphetamine (MET) 40 tests / 1-DME-102</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DME-102</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:04.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959156</udiDi>
    <basicUdiDi>59026439BRTDBZQR</basicUdiDi>
    <tradeName>05902643959156</tradeName>
    <deviceName>Benzodiazepines (BZO) 40 tests / 1-DBZ-102</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160504</emdnCode>
    <emdnDescription>BENZODIAZEPINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DBZ-102</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:03.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959149</udiDi>
    <basicUdiDi>59026439BRTDATQA</basicUdiDi>
    <tradeName>05902643959149</tradeName>
    <deviceName>Adulteration Test 25 t. / DAT-111</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DAT-111</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:02.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959132</udiDi>
    <basicUdiDi>59026439BRTDAMPU</basicUdiDi>
    <tradeName>05902643959132</tradeName>
    <deviceName>Amphetamine (AMP) 40 tests / DAM-102.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DAM-102</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:01.651Z</lastUpdated>
  </row>
</eudamedExport>