<?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-GEFB-606bHGGL</udiDi>
    <basicUdiDi>B-GEFB-606bHGGL</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>GEFB-606b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:40:46.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A054D6</udiDi>
    <basicUdiDi>B-A054D6</basicUdiDi>
    <tradeName>D-A054D6</tradeName>
    <deviceName>INDICAID™ Fecal Occult Blood (FOB) Rapid 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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Fecal Occult Blood (FOB) Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:42:57.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84352873423U4AF</udiDi>
    <basicUdiDi>B-84352873423U4AF</basicUdiDi>
    <tradeName>D-84352873423U4AF</tradeName>
    <deviceName>Fecal Occult Blood cassette</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</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>4325225</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:40:46.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873423007</udiDi>
    <basicUdiDi>B-84352873423007</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>Fecal Occult Blood cassette</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</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>4325225</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:34:48.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646AFP001FJB3E</udiDi>
    <basicUdiDi>B-697424646AFP001FJB3E</basicUdiDi>
    <tradeName>Alpha Fetal Protein FIA Test (Serum/Plasma)</tradeName>
    <deviceName>Alpha Fetal Protein FIA Test (Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFP-3012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:34.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646AFP000FJ82M</udiDi>
    <basicUdiDi>B-697424646AFP000FJ82M</basicUdiDi>
    <tradeName>Alpha Fetal Protein FIA Test (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Alpha Fetal Protein FIA Test (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFP-4012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:33.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120111587</udiDi>
    <basicUdiDi>B-697177120111587</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-U21(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:09.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757990606QH</udiDi>
    <basicUdiDi>B-693757990606QH</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB)Test</tradeName>
    <deviceName>Fecal Occult Blood (FOB)Test</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</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>Artık piyasada değil</deviceStatus>
    <reference>FOB strip cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:43.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69219637108198R</udiDi>
    <basicUdiDi>B-69219637108198R</basicUdiDi>
    <tradeName>Rapid Fecal Occult Blood Test Card</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1M01C4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:15.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6909620WHSTF97DD</udiDi>
    <basicUdiDi>B-6909620WHSTF97DD</basicUdiDi>
    <tradeName>One-Step Immunological Transferrin Test</tradeName>
    <deviceName>Occult Blood Tests (Transferrin Tests)</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-FOB-S0x0201; WH-FOB-S0x0202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:10.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6909620WHSFOBTFLHR2</udiDi>
    <basicUdiDi>B-6909620WHSFOBTFLHR2</basicUdiDi>
    <tradeName>One-step Immunological Hemoglobin and Transferrin Test</tradeName>
    <deviceName>Occult Blood Tests (Hemoglobin and Transferrin Tests)</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-FOB-S0x0401; WH-FOB-S0x0402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:00.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990639UJ</udiDi>
    <basicUdiDi>B-6430030990639UJ</basicUdiDi>
    <tradeName>Actim Combi® Hemoglobin Transferrin</tradeName>
    <deviceName>Actim Combi® Hemoglobin Transferrin</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>30322ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:08.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990042T9</udiDi>
    <basicUdiDi>B-6430030990042T9</basicUdiDi>
    <tradeName>Actim® Fecal Blood Buffer</tradeName>
    <deviceName>Actim® Fecal Blood Buffer</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</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>30372ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:09.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990028TF</udiDi>
    <basicUdiDi>B-6430030990028TF</basicUdiDi>
    <tradeName>Actim® Fecal Blood dipsticks</tradeName>
    <deviceName>Actim® Fecal Blood dipsticks</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</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>30361ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:05.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990011SW</udiDi>
    <basicUdiDi>B-6430030990011SW</basicUdiDi>
    <tradeName>Actim® Fecal Blood</tradeName>
    <deviceName>Actim® Fecal Blood</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</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>30331ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:04.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5C02C1UY</udiDi>
    <basicUdiDi>B-5C02C1UY</basicUdiDi>
    <tradeName>Cancer Embryo Antigen Test (FIA)</tradeName>
    <deviceName>Cancer Embryo Antigen Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5C02C1-25-EU, 5C02C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:19.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5C01C1UT</udiDi>
    <basicUdiDi>B-5C01C1UT</basicUdiDi>
    <tradeName>Alpha-Fetoprotein Test (FIA)</tradeName>
    <deviceName>Alpha-Fetoprotein Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5C01C1-25-EU, 5C01C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:19.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232251876</udiDi>
    <basicUdiDi>B-06976232251876</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Fecal Occult Blood/Transferrin (FOB/TF) Combo Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA05-07-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:05.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232251869</udiDi>
    <basicUdiDi>B-06976232251869</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</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>CA05-02-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:03.584Z</lastUpdated>
  </row>
</eudamedExport>