<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SAC2022017EF</udiDi>
    <basicUdiDi>B-SAC2022017EF</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022017</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:24.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022016ED</udiDi>
    <basicUdiDi>B-SAC2022016ED</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022016</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:19.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022003E4</udiDi>
    <basicUdiDi>B-SAC2022003E4</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022003</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:46.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OGGEFOB-601bKD</udiDi>
    <basicUdiDi>B-OGGEFOB-601bKD</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test Strip (Feces)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test Strip (Feces)</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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB-601b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:28.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OGGEFOB-601CbS3</udiDi>
    <basicUdiDi>B-OGGEFOB-601CbS3</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test Strip (Feces)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test Strip (Feces)</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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB-601Cb</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:27.925Z</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-GKPD180XN</udiDi>
    <basicUdiDi>B-GKPD180XN</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB) Detection Kit (Immunofluorescence Chromatography</tradeName>
    <deviceName>Fecal Occult Blood (FOB) 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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:35.199Z</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-GEFTHRA-T636a7B</udiDi>
    <basicUdiDi>B-GEFTHRA-T636a7B</basicUdiDi>
    <tradeName>FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces)</tradeName>
    <deviceName>FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces)</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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFTHRA-T636a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:20.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEFOB/TF-602aG5</udiDi>
    <basicUdiDi>B-GEFOB/TF-602aG5</basicUdiDi>
    <tradeName>Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB/TF-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:18.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEFOB-606bHGWL</udiDi>
    <basicUdiDi>B-GEFOB-606bHGWL</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test Device (Feces)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test Device (Feces)</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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB-606b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:13.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEFOB-602jY3</udiDi>
    <basicUdiDi>B-GEFOB-602jY3</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test Cassette (Feces)</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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB-602j</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:12.409Z</lastUpdated>
  </row>
</eudamedExport>