<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-I0215ND</udiDi>
    <basicUdiDi>B-I0215ND</basicUdiDi>
    <tradeName>Ceruloplasmin</tradeName>
    <deviceName>Ceruloplasmin</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010301</emdnCode>
    <emdnDescription>CERULOPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0215</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:37.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GETF-606aHGUV</udiDi>
    <basicUdiDi>B-GETF-606aHGUV</basicUdiDi>
    <tradeName>Transferrin Rapid Test Device (Feces)</tradeName>
    <deviceName>Transferrin 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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GETF-606a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:53.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GETF-606a5A</udiDi>
    <basicUdiDi>B-GETF-606a5A</basicUdiDi>
    <tradeName>Transferrin Rapid Test Device (Feces)</tradeName>
    <deviceName>Transferrin 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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GETF-606a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:49.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GETF-602aHGTZ</udiDi>
    <basicUdiDi>B-GETF-602aHGTZ</basicUdiDi>
    <tradeName>Transferrin Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Transferrin Rapid Test Cassette (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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GETF-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:48.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GETF-602a4W</udiDi>
    <basicUdiDi>B-GETF-602a4W</basicUdiDi>
    <tradeName>Transferrin Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Transferrin 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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GETF-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:48.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GETF-601aHGTS</udiDi>
    <basicUdiDi>B-GETF-601aHGTS</basicUdiDi>
    <tradeName>Transferrin Rapid Test Strip (Feces)</tradeName>
    <deviceName>Transferrin Rapid Test Strip (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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GETF-601a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:46.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GETF-601a4T</udiDi>
    <basicUdiDi>B-GETF-601a4T</basicUdiDi>
    <tradeName>Transferrin Rapid Test Strip (Feces)</tradeName>
    <deviceName>Transferrin Rapid Test Strip (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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GETF-601a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:42.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05090077V</udiDi>
    <basicUdiDi>B-ECH05090077V</basicUdiDi>
    <tradeName>D-ECH05090077V</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0509007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:37.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05080077N</udiDi>
    <basicUdiDi>B-ECH05080077N</basicUdiDi>
    <tradeName>D-ECH05080077N</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0508007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:35.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05070077F</udiDi>
    <basicUdiDi>B-ECH05070077F</basicUdiDi>
    <tradeName>D-ECH05070077F</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0507007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:31.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050600778</udiDi>
    <basicUdiDi>B-ECH050600778</basicUdiDi>
    <tradeName>D-ECH050600778</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0506007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:09.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05050076Z</udiDi>
    <basicUdiDi>B-ECH05050076Z</basicUdiDi>
    <tradeName>D-ECH05050076Z</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0505007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:45:35.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05040076S</udiDi>
    <basicUdiDi>B-ECH05040076S</basicUdiDi>
    <tradeName>D-ECH05040076S</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0504007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:45:04.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05030076K</udiDi>
    <basicUdiDi>B-ECH05030076K</basicUdiDi>
    <tradeName>D-ECH05030076K</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0503007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:20.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05020076C</udiDi>
    <basicUdiDi>B-ECH05020076C</basicUdiDi>
    <tradeName>D-ECH05020076C</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:34.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050100765</udiDi>
    <basicUdiDi>B-ECH050100765</basicUdiDi>
    <tradeName>D-ECH050100765</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:45.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010900769</udiDi>
    <basicUdiDi>B-ECH010900769</basicUdiDi>
    <tradeName>D-ECH010900769</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0109007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:15.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01060605Q</udiDi>
    <basicUdiDi>B-ECH01060605Q</basicUdiDi>
    <tradeName>D-ECH01060605Q</tradeName>
    <deviceName>Urinary Microalbumin (mAlb)</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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0106060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:26.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01050605H</udiDi>
    <basicUdiDi>B-ECH01050605H</basicUdiDi>
    <tradeName>D-ECH01050605H</tradeName>
    <deviceName>Urinary Microalbumin (mAlb)</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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:20.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01050075D</udiDi>
    <basicUdiDi>B-ECH01050075D</basicUdiDi>
    <tradeName>D-ECH01050075D</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:12.088Z</lastUpdated>
  </row>
</eudamedExport>