<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A038D8</udiDi>
    <basicUdiDi>B-A038D8</basicUdiDi>
    <tradeName>INDICAID™ Bladder Cancer Marker NMP22 Test</tradeName>
    <deviceName>INDICAID™ Bladder Cancer Marker NMP22 Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030123</emdnCode>
    <emdnDescription>NUCLEAR MATRIX PROTEIN 22</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Bladder Cancer Marker NMP22 Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:41:54.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GENMP22-102aHGGZ</udiDi>
    <basicUdiDi>B-GENMP22-102aHGGZ</basicUdiDi>
    <tradeName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</tradeName>
    <deviceName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030123</emdnCode>
    <emdnDescription>NUCLEAR MATRIX PROTEIN 22</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GENMP22-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:27.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GENMP22-102a47</udiDi>
    <basicUdiDi>B-GENMP22-102a47</basicUdiDi>
    <tradeName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</tradeName>
    <deviceName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030123</emdnCode>
    <emdnDescription>NUCLEAR MATRIX PROTEIN 22</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GENMP22-102a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:26.519Z</lastUpdated>
  </row>
</eudamedExport>