<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936983190701</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402H-01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:13:01.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-602003RS</udiDi>
    <basicUdiDi>B-nvm-602003RS</basicUdiDi>
    <tradeName>NADAL® PSA Test (CE0197)</tradeName>
    <deviceName>PSA Test (CE0197)</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>602003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:29.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W31-SV5</udiDi>
    <basicUdiDi>B-W31-SV5</basicUdiDi>
    <tradeName>D-W31-SV5</tradeName>
    <deviceName>One Step Prostate Specific Antigen (PSA) Serum/Plasma Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W31-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:07.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W31-S4PNE</udiDi>
    <basicUdiDi>B-W31-S4PNE</basicUdiDi>
    <tradeName>D-W31-S4PNE</tradeName>
    <deviceName>One Step Prostate Specific Antigen (PSA)  Whole Blood/Serum/Plasma Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W31-S4P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:05.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W31-CU5</udiDi>
    <basicUdiDi>B-W31-CU5</basicUdiDi>
    <tradeName>D-W31-CU5</tradeName>
    <deviceName>One Step Prostate Specific Antigen (PSA) Serum/Plasma Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W31-C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:04.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W31-C4PKW</udiDi>
    <basicUdiDi>B-W31-C4PKW</basicUdiDi>
    <tradeName>D-W31-C4PKW</tradeName>
    <deviceName>One Step Prostate Specific Antigen (PSA)  Whole Blood/Serum/Plasma Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W31-C4P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:03.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W230HU</udiDi>
    <basicUdiDi>B-W230HU</basicUdiDi>
    <tradeName>D-W230HU</tradeName>
    <deviceName>Finecare™ FPSA (Free Prostate Specific Antigen) Rapid Quantitative Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:00.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TPS-U402U6</udiDi>
    <basicUdiDi>B-TPS-U402U6</basicUdiDi>
    <tradeName>D-TPS-U402U6</tradeName>
    <deviceName>PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device  (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-U402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:59:39.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD185XY</udiDi>
    <basicUdiDi>B-GKPD185XY</basicUdiDi>
    <tradeName>tPSA Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>tPSA Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD185</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:42.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD184XW</udiDi>
    <basicUdiDi>B-GKPD184XW</basicUdiDi>
    <tradeName>PSA Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>PSA Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD184</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:41.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-402aHG87</udiDi>
    <basicUdiDi>B-GEPSA-402aHG87</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole Blood /Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:41.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-402a6T</udiDi>
    <basicUdiDi>B-GEPSA-402a6T</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:40.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-401aHG7Y</udiDi>
    <basicUdiDi>B-GEPSA-401aHG7Y</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Strip (Whole Blood /Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:38.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-401a6Q</udiDi>
    <basicUdiDi>B-GEPSA-401a6Q</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Strip (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:34.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-302aHG7S</udiDi>
    <basicUdiDi>B-GEPSA-302aHG7S</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:34.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-302a6L</udiDi>
    <basicUdiDi>B-GEPSA-302a6L</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:33.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-301aHG7K</udiDi>
    <basicUdiDi>B-GEPSA-301aHG7K</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Strip (Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-301a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:32.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEPSA-301a6H</udiDi>
    <basicUdiDi>B-GEPSA-301a6H</basicUdiDi>
    <tradeName>Prostate Specific Antigen (PSA) Rapid Test Strip (Serum/Plasma)</tradeName>
    <deviceName>Prostate Specific Antigen (PSA) Rapid Test</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEPSA-301a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:29.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180729002NP</udiDi>
    <basicUdiDi>B-CNM0000180729002NP</basicUdiDi>
    <tradeName>D-CNM0000180729002NP</tradeName>
    <deviceName>Prostate Specific Antigen Rapid Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:31.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-801080NW</udiDi>
    <basicUdiDi>B-801080NW</basicUdiDi>
    <tradeName>PROFAR Test PSA</tradeName>
    <deviceName>PROFAR TEST PSA</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801080</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:42.338Z</lastUpdated>
  </row>
</eudamedExport>