<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FIMG-402aHGRE</udiDi>
    <basicUdiDi>B-FIMG-402aHGRE</basicUdiDi>
    <tradeName>β2-MG Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIMG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:11.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMG-402a2T</udiDi>
    <basicUdiDi>B-FIMG-402a2T</basicUdiDi>
    <tradeName>β2-MG Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>β2-MG Quantitative Test Kit (Time-Resolved FIA)</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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIMG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:10.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FEAFP-302aTV</udiDi>
    <basicUdiDi>B-FEAFP-302aTV</basicUdiDi>
    <tradeName>AFP Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>AFP Quantitative Test Kit (Time-Resolved FIA)</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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEAFP-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:19.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FEAFP-302aHGQH</udiDi>
    <basicUdiDi>B-FEAFP-302aHGQH</basicUdiDi>
    <tradeName>AFP Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEAFP-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:13.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050405575</udiDi>
    <basicUdiDi>B-ECH050405575</basicUdiDi>
    <tradeName>D-ECH050405575</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0504055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:45:11.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05030556W</udiDi>
    <basicUdiDi>B-ECH05030556W</basicUdiDi>
    <tradeName>D-ECH05030556W</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0503055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:25.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05020556P</udiDi>
    <basicUdiDi>B-ECH05020556P</basicUdiDi>
    <tradeName>D-ECH05020556P</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:36.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05010556G</udiDi>
    <basicUdiDi>B-ECH05010556G</basicUdiDi>
    <tradeName>D-ECH05010556G</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:04.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01090556L</udiDi>
    <basicUdiDi>B-ECH01090556L</basicUdiDi>
    <tradeName>D-ECH01090556L</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0109055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:19.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01030555A</udiDi>
    <basicUdiDi>B-ECH01030555A</basicUdiDi>
    <tradeName>D-ECH01030555A</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0103055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:19.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010554U</udiDi>
    <basicUdiDi>B-ECH01010554U</basicUdiDi>
    <tradeName>D-ECH01010554U</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:29.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01897Z</udiDi>
    <basicUdiDi>B-DT01897Z</basicUdiDi>
    <tradeName>Unicorn-AFP</tradeName>
    <deviceName>Unicorn-AFP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0189</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:08.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01907J</udiDi>
    <basicUdiDi>B-DT01907J</basicUdiDi>
    <tradeName>Unicorn-AFP</tradeName>
    <deviceName>Unicorn-AFP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0190</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:06.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76403FM</udiDi>
    <basicUdiDi>B-DC76403FM</basicUdiDi>
    <tradeName>iStar-AFP</tradeName>
    <deviceName>iStar-AFP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76403</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:14:07.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76402FK</udiDi>
    <basicUdiDi>B-DC76402FK</basicUdiDi>
    <tradeName>iStar-AFP</tradeName>
    <deviceName>iStar-AFP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76402</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:14:06.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76401FH</udiDi>
    <basicUdiDi>B-DC76401FH</basicUdiDi>
    <tradeName>iStar-AFP</tradeName>
    <deviceName>iStar-AFP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:48.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76400FF</udiDi>
    <basicUdiDi>B-DC76400FF</basicUdiDi>
    <tradeName>iStar-AFP</tradeName>
    <deviceName>iStar-AFP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:47.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76042FB</udiDi>
    <basicUdiDi>B-DC76042FB</basicUdiDi>
    <tradeName>iStar-AFP</tradeName>
    <deviceName>iStar-AFP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:30.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-AFP-42XM</udiDi>
    <basicUdiDi>B-D-AFP-42XM</basicUdiDi>
    <tradeName>D-D-AFP-42XM</tradeName>
    <deviceName>Alpha-fetoprotein Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-AFP-42</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:04.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-S015UM</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-S015UM</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-S015UM</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Latex Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-S015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:13:25.034Z</lastUpdated>
  </row>
</eudamedExport>