<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04049325003286</udiDi>
    <basicUdiDi>B-04049325003286</basicUdiDi>
    <tradeName>5-HIAA ELISA</tradeName>
    <deviceName>5-HIAA ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039004</emdnCode>
    <emdnDescription>5 HIAA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE59131</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:08:52.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325003279</udiDi>
    <basicUdiDi>B-04049325003279</basicUdiDi>
    <tradeName>Serotonin ELISA</tradeName>
    <deviceName>Serotonin ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039011</emdnCode>
    <emdnDescription>SEROTONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE59121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:08:46.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321616</udiDi>
    <basicUdiDi>B-03770024321616</basicUdiDi>
    <tradeName>03770024321616</tradeName>
    <deviceName>Chromogranin A New Gen. ELISA</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039014</emdnCode>
    <emdnDescription>CHROMOGRANIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30208352</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:32:52.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321340</udiDi>
    <basicUdiDi>B-03770024321340</basicUdiDi>
    <tradeName>RG-AFP</tradeName>
    <deviceName>OCFA07-AFP</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCFA07-AFP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:32:04.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321173</udiDi>
    <basicUdiDi>B-03770024321173</basicUdiDi>
    <tradeName>03770024321173</tradeName>
    <deviceName>ELSA-NSE</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELSA-NSE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:37.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321098</udiDi>
    <basicUdiDi>B-03770024321098</basicUdiDi>
    <tradeName>03770024321098</tradeName>
    <deviceName>ELSA2-AFP</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELSA2-AFP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:24.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321050</udiDi>
    <basicUdiDi>B-03770024321050</basicUdiDi>
    <tradeName>03770024321050</tradeName>
    <deviceName>CGA-RIACT</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039014</emdnCode>
    <emdnDescription>CHROMOGRANIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGA-RIACT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:20.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321074</udiDi>
    <basicUdiDi>B-03770024321074</basicUdiDi>
    <tradeName>03770024321074</tradeName>
    <deviceName>CGA-ELISA-NG</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039014</emdnCode>
    <emdnDescription>CHROMOGRANIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGA-ELISA-NG</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:19.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321067</udiDi>
    <basicUdiDi>B-03770024321067</basicUdiDi>
    <tradeName>03770024321067</tradeName>
    <deviceName>CGA-ELISA</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039014</emdnCode>
    <emdnDescription>CHROMOGRANIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGA-ELISA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:18.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0003YF</udiDi>
    <basicUdiDi>B-02B0003YF</basicUdiDi>
    <tradeName>D-02B0003YF</tradeName>
    <deviceName>β2-Microglobulin/Cystatin C Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1O001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:32.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270111V5</udiDi>
    <basicUdiDi>B-0270111V5</basicUdiDi>
    <tradeName>D-0270111V5</tradeName>
    <deviceName>FOB Test</deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:24:26.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021303</udiDi>
    <basicUdiDi>B-00816426021303</basicUdiDi>
    <tradeName>K-ASSAY Beta-2 Microglobulin Urine Calibrator</tradeName>
    <deviceName>Beta-2 Microglobulin Urine Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-282C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:14.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021297</udiDi>
    <basicUdiDi>B-00816426021297</basicUdiDi>
    <tradeName>K-ASSAY Beta-2 Microglobulin Serum/Plasma Calibrator</tradeName>
    <deviceName>Beta-2 Microglobulin Serum/Plasma Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-281C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:14.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021280</udiDi>
    <basicUdiDi>B-00816426021280</basicUdiDi>
    <tradeName>K-ASSAY Beta-2 Microglobulin</tradeName>
    <deviceName>Beta-2 Microglobulin Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-280</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:13.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059100013</udiDi>
    <basicUdiDi>B-00083059100013</basicUdiDi>
    <tradeName>EZ Detect Colon Disease Test</tradeName>
    <deviceName>EZ Detect Colon Disease Test</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:19.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059010015</udiDi>
    <basicUdiDi>B-00083059010015</basicUdiDi>
    <tradeName>EZ Detect™ Fecal Occult Blood Test Professional</tradeName>
    <deviceName>EZ Detect™ Fecal Occult Blood Test Professional</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:43.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059010008</udiDi>
    <basicUdiDi>B-00083059010008</basicUdiDi>
    <tradeName>EZ Detect™ Home Test for Hidden Blood in The Stool</tradeName>
    <deviceName>EZ Detect Home Test for Hidden Blood in The Stool</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:41.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000012807195076RJ</udiDi>
    <basicUdiDi>B-000012807195076RJ</basicUdiDi>
    <tradeName>Fecal Occult Blood Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT143</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:55.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000012807185066R4</udiDi>
    <basicUdiDi>B-000012807185066R4</basicUdiDi>
    <tradeName>AFP Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>AFP Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:38.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133044216</udiDi>
    <basicUdiDi>880613300123BL</basicUdiDi>
    <tradeName>ichroma™ AFP Neo</tradeName>
    <deviceName>ichroma™ AFP Neo</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-156</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:15.204Z</lastUpdated>
  </row>
</eudamedExport>