<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TP601Z8</udiDi>
    <basicUdiDi>B-TP601Z8</basicUdiDi>
    <tradeName>Total Protein Reagent Kit</tradeName>
    <deviceName>Total Protein Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP6011Y, TP6012Y, TP6013Y, TP6014Y, TP6015Y, TP6011N, TP6012N, TP6013N, TP6014N, TP6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:59:38.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PROTEINE-TOTALIY6</udiDi>
    <basicUdiDi>B-PROTEINE-TOTALIY6</basicUdiDi>
    <tradeName>PROTEINE TOTALI LR</tradeName>
    <deviceName>PROTEINE TOTALI LR</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC245-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T14:12:33.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05030636V</udiDi>
    <basicUdiDi>B-ECH05030636V</basicUdiDi>
    <tradeName>D-ECH05030636V</tradeName>
    <deviceName>Cerebrospinal Fluid/Urinary Total Protein（CSF/U-TP）</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0503063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:28.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05020636N</udiDi>
    <basicUdiDi>B-ECH05020636N</basicUdiDi>
    <tradeName>D-ECH05020636N</tradeName>
    <deviceName>Cerebrospinal Fluid/Urinary Total Protein（CSF/U-TP）</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:41.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05010636F</udiDi>
    <basicUdiDi>B-ECH05010636F</basicUdiDi>
    <tradeName>D-ECH05010636F</tradeName>
    <deviceName>Cerebrospinal Fluid/Urinary Total Protein（CSF/U-TP）</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:08.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01070085V</udiDi>
    <basicUdiDi>B-ECH01070085V</basicUdiDi>
    <tradeName>D-ECH01070085V</tradeName>
    <deviceName>Total Protein (TP)</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0107008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:53.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01060635W</udiDi>
    <basicUdiDi>B-ECH01060635W</basicUdiDi>
    <tradeName>D-ECH01060635W</tradeName>
    <deviceName>Cerebrospinal Fluid/Urinary Total Protein（CSF/U-TP）</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0106063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:27.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01050635P</udiDi>
    <basicUdiDi>B-ECH01050635P</basicUdiDi>
    <tradeName>D-ECH01050635P</tradeName>
    <deviceName>Cerebrospinal Fluid/Urinary Total Protein（CSF/U-TP）</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:21.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01050085F</udiDi>
    <basicUdiDi>B-ECH01050085F</basicUdiDi>
    <tradeName>D-ECH01050085F</tradeName>
    <deviceName>Total Protein (TP)</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:10.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010206352</udiDi>
    <basicUdiDi>B-ECH010206352</basicUdiDi>
    <tradeName>D-ECH010206352</tradeName>
    <deviceName>Cerebrospinal Fluid/Urinary Total Protein（CSF/U-TP）</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0102063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:11.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010634T</udiDi>
    <basicUdiDi>B-ECH01010634T</basicUdiDi>
    <tradeName>D-ECH01010634T</tradeName>
    <deviceName>Cerebrospinal Fluid/Urinary Total Protein（CSF/U-TP）</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:40.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010084K</udiDi>
    <basicUdiDi>B-ECH01010084K</basicUdiDi>
    <tradeName>D-ECH01010084K</tradeName>
    <deviceName>Total Protein (TP)</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:23.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0188LZ</udiDi>
    <basicUdiDi>B-C0188LZ</basicUdiDi>
    <tradeName>Total Proteins</tradeName>
    <deviceName>Total Proteins</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0188</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:44.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77953KE</udiDi>
    <basicUdiDi>B-77953KE</basicUdiDi>
    <tradeName>SPOTCHEM D TP</tradeName>
    <deviceName>SPOTCHEM D TP</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77953</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:08.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77402J4</udiDi>
    <basicUdiDi>B-77402J4</basicUdiDi>
    <tradeName>SPOTCHEM II Total Protein</tradeName>
    <deviceName>SPOTCHEM II Total Protein</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:06.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77167JH</udiDi>
    <basicUdiDi>B-77167JH</basicUdiDi>
    <tradeName>SPOTCHEM II Total Protein</tradeName>
    <deviceName>SPOTCHEM II Total Protein</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77167</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:35.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465986RZ</udiDi>
    <basicUdiDi>B-465986RZ</basicUdiDi>
    <tradeName>SYNCHRON Systems Total Protein Reagent</tradeName>
    <deviceName>SYNCHRON Systems Total Protein Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465986</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:38.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-442740PL</udiDi>
    <basicUdiDi>B-442740PL</basicUdiDi>
    <tradeName>Total Protein Reagent (TP 2 x 300)</tradeName>
    <deviceName>Total Protein Reagent (TP 2 x 300)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442740</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:01.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972838809210</udiDi>
    <basicUdiDi>B-16972838809210</basicUdiDi>
    <tradeName>E7GENPRO</tradeName>
    <deviceName>E7 Protein Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>FAMID Biomedical Technology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051665</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3028</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:53:12.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972838809203</udiDi>
    <basicUdiDi>B-16972838809203</basicUdiDi>
    <tradeName>E7GENPRO</tradeName>
    <deviceName>E7 Protein Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>FAMID Biomedical Technology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051665</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3027</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:53:11.728Z</lastUpdated>
  </row>
</eudamedExport>