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<eudamedExport entity="devices">
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    <udiDi>06978465237153</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <tradeName>Heart-type Fatty Acid-Binding Protein Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Total Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:45.646Z</lastUpdated>
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    <udiDi>06978465232707</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <tradeName>Heart-type Fatty Acid-Binding Protein Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Total Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:21:09.521Z</lastUpdated>
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  <row>
    <udiDi>06978465232653</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <tradeName>Heart-type Fatty Acid-Binding Protein Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Total Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:21:08.328Z</lastUpdated>
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    <udiDi>06970877688004</udiDi>
    <basicUdiDi>B-06970877688004</basicUdiDi>
    <tradeName>cTnI/ Myoglobin Test Kit（colloidal gold immunochromatographic assay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:50.355Z</lastUpdated>
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  <row>
    <udiDi>06970877687007</udiDi>
    <basicUdiDi>B-06970877687007</basicUdiDi>
    <tradeName>cTnI Test Kit（colloidal gold immunochromatographic assay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:49.158Z</lastUpdated>
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  <row>
    <udiDi>06970877686000</udiDi>
    <basicUdiDi>B-06970877686000</basicUdiDi>
    <tradeName>cTnI/CK-MB/Myoglobin Test Kit（colloidal gold immunochromatographic assay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:47.957Z</lastUpdated>
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  <row>
    <udiDi>06970581432061</udiDi>
    <basicUdiDi>B-06970581432061</basicUdiDi>
    <tradeName>Accu-Tell® Myoglobin/CK-MB/Troponin I Combo Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Myoglobin/CK-MB/Troponin I Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-E71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:40.330Z</lastUpdated>
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  <row>
    <udiDi>06970581432054</udiDi>
    <basicUdiDi>B-06970581432054</basicUdiDi>
    <tradeName>Accu-Tell® NT-proBNP Cassette (Whole Blood/ Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Myoglobin Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-B111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:34.349Z</lastUpdated>
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  <row>
    <udiDi>06970581432047</udiDi>
    <basicUdiDi>B-06970581432047</basicUdiDi>
    <tradeName>Accu-Tell® Myoglobin Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Myoglobin Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-B68</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:33.225Z</lastUpdated>
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  <row>
    <udiDi>06970581432030</udiDi>
    <basicUdiDi>B-06970581432030</basicUdiDi>
    <tradeName>Accu-Tell®CK-MB Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® CK-MB Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-B66</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:30.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581432016</udiDi>
    <basicUdiDi>B-06970581432016</basicUdiDi>
    <tradeName>Accu-Tell® CRP Semi-Quantitative Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® CRP Test Semi-Quantitative Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-B251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:23.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430463</udiDi>
    <basicUdiDi>B-06970581430463</basicUdiDi>
    <tradeName>Accu-Tell® Troponin I Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Rapid Troponin I Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-B59</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:20.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816735</udiDi>
    <basicUdiDi>B-06952804816735</basicUdiDi>
    <tradeName>Cardiac Markers Combo Rapid Test</tradeName>
    <deviceName>Cardiac Markers Combo 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>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMC-W23M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:42.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816728</udiDi>
    <basicUdiDi>B-06952804816728</basicUdiDi>
    <tradeName>Myoglobin Rapid Test</tradeName>
    <deviceName>Myoglobin 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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYO-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:40.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816711</udiDi>
    <basicUdiDi>B-06952804816711</basicUdiDi>
    <tradeName>Cardiac Troponin I Rapid Test</tradeName>
    <deviceName>Cardiac Troponin I 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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRO-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:37.294Z</lastUpdated>
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  <row>
    <udiDi>06952804814984</udiDi>
    <basicUdiDi>B-06952804814984</basicUdiDi>
    <tradeName>Myoglobin Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Myoglobin Chemiluminescence Immunoassay Test Kit</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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G105A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:28:46.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804814953</udiDi>
    <basicUdiDi>B-06952804814953</basicUdiDi>
    <tradeName>High-sensitive Cardiac Troponin I Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>High-sensitive Cardiac Troponin I Chemiluminescence Immunoassay Test Kit</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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G104A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:28:43.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804810788</udiDi>
    <basicUdiDi>B-06952804810788</basicUdiDi>
    <tradeName>Cardiac Troponin I Rapid Test Device (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Cardiac Troponin I 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>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRO-W23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:04.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803117</udiDi>
    <basicUdiDi>B-06952804803117</basicUdiDi>
    <tradeName>Myoglobin FIA</tradeName>
    <deviceName>Myoglobin FIA</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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYO-W23G3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:02.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802479</udiDi>
    <basicUdiDi>B-06952804802479</basicUdiDi>
    <tradeName>Heart Fatty Acid Bindingprotein Chemiluminescence  Immunoassay Test Kit</tradeName>
    <deviceName>Heart Fatty Acid Bindingprotein Chemiluminescence  Immunoassay Test Kit</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>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G103A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:56.471Z</lastUpdated>
  </row>
</eudamedExport>