<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455-BF-C013MQ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C013MQ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C013MQ</tradeName>
    <deviceName>Insulin Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:07.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C021MP</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C021MP</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C021MP</tradeName>
    <deviceName>C-Peptide Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:06.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C012MN</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C012MN</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C012MN</tradeName>
    <deviceName>Insulin Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:04.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C011ML</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C011ML</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C011ML</tradeName>
    <deviceName>Insulin Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:04.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990707UA</udiDi>
    <basicUdiDi>B-6430030990707UA</basicUdiDi>
    <tradeName>Actim Combi® Hemoglobin Transferrin Controls</tradeName>
    <deviceName>Actim Combi® Hemoglobin Transferrin Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>30310ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:12.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990691UL</udiDi>
    <basicUdiDi>B-6430030990691UL</basicUdiDi>
    <tradeName>Actim® Calprotectin Controls</tradeName>
    <deviceName>Actim® Calprotectin Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35000ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:08.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990547UC</udiDi>
    <basicUdiDi>B-6430030990547UC</basicUdiDi>
    <tradeName>Actim® Partus Controls</tradeName>
    <deviceName>Actim® Partus Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31900ETAL</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:00.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990516TZ</udiDi>
    <basicUdiDi>B-6430030990516TZ</basicUdiDi>
    <tradeName>Actim® PROM Controls</tradeName>
    <deviceName>Actim® PROM Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30800ETAL</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:56.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990233TJ</udiDi>
    <basicUdiDi>B-6430030990233TJ</basicUdiDi>
    <tradeName>Actim® Pancreatitis Controls</tradeName>
    <deviceName>Actim® Pancreatitis Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32700ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:28.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990172TP</udiDi>
    <basicUdiDi>B-6430030990172TP</basicUdiDi>
    <tradeName>Actim® Partus Controls</tradeName>
    <deviceName>Actim® Partus Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31900ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:22.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990110SZ</udiDi>
    <basicUdiDi>B-6430030990110SZ</basicUdiDi>
    <tradeName>Actim® PROM Controls</tradeName>
    <deviceName>Actim® PROM Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30800ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:16.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990066TP</udiDi>
    <basicUdiDi>B-6430030990066TP</basicUdiDi>
    <tradeName>Actim® Fecal Blood Controls</tradeName>
    <deviceName>Actim® Fecal Blood Controls</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30300ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:10.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725678</udiDi>
    <basicUdiDi>88001117IPCA02FA05WA</basicUdiDi>
    <tradeName>SDB HbA1c Control</tradeName>
    <deviceName>SDB HbA1c Control</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10A1CC20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:42:33.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST2400DP</udiDi>
    <basicUdiDi>B-ST2400DP</basicUdiDi>
    <tradeName>Cystatin C (GFR) control kit</tradeName>
    <deviceName>Cystatin C (GFR) control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST2400</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:44:30.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST2300DJ</udiDi>
    <basicUdiDi>B-ST2300DJ</basicUdiDi>
    <tradeName>Troponin I control kit</tradeName>
    <deviceName>Troponin I control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST2300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:44:29.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST2000D3</udiDi>
    <basicUdiDi>B-ST2000D3</basicUdiDi>
    <tradeName>iFOB control kit</tradeName>
    <deviceName>iFOB control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:49.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST1700DX</udiDi>
    <basicUdiDi>B-ST1700DX</basicUdiDi>
    <tradeName>Ferritin control kit</tradeName>
    <deviceName>Ferritin control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1700</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:42.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST1400DG</udiDi>
    <basicUdiDi>B-ST1400DG</basicUdiDi>
    <tradeName>Lipoprotein (a) control kit</tradeName>
    <deviceName>Lipoprotein (a) control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1400</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:36.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST1100CZ</udiDi>
    <basicUdiDi>B-ST1100CZ</basicUdiDi>
    <tradeName>HbA1c control kit</tradeName>
    <deviceName>HbA1c control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:30.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST1005D6</udiDi>
    <basicUdiDi>B-ST1005D6</basicUdiDi>
    <tradeName>hsCRP control kit</tradeName>
    <deviceName>hsCRP control kit</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1005</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:19.001Z</lastUpdated>
  </row>
</eudamedExport>