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<eudamedExport entity="devices">
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    <udiDi>06974674891896</udiDi>
    <basicUdiDi>B-06974674891896</basicUdiDi>
    <tradeName>Nucleic Acid Extraction or Purification Kit</tradeName>
    <deviceName>Nucleic Acid Extraction or Purification Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-04-0034</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:36.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891889</udiDi>
    <basicUdiDi>B-06974674891889</basicUdiDi>
    <tradeName>Nucleic Acid Extraction or Purification Kit</tradeName>
    <deviceName>Nucleic Acid Extraction or Purification Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-04-0021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:35.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891872</udiDi>
    <basicUdiDi>B-06974674891872</basicUdiDi>
    <tradeName>Nucleic Acid Extraction or Purification Kit</tradeName>
    <deviceName>Nucleic Acid Extraction or Purification Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-04-0035</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:32.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891865</udiDi>
    <basicUdiDi>B-06974674891865</basicUdiDi>
    <tradeName>Nucleic Acid Extraction or Purification Kit</tradeName>
    <deviceName>Nucleic Acid Extraction or Purification Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-04-0069</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:31.169Z</lastUpdated>
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  <row>
    <udiDi>06974674891858</udiDi>
    <basicUdiDi>B-06974674891858</basicUdiDi>
    <tradeName>Mutation of SARS-CoV-2 nucleic acid Detection Kit (Real Time PCR)</tradeName>
    <deviceName>Mutation of SARS-CoV-2 nucleic acid Detection Kit (Real Time PCR)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0129</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:30.370Z</lastUpdated>
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  <row>
    <udiDi>06974674891841</udiDi>
    <basicUdiDi>B-06974674891841</basicUdiDi>
    <tradeName>Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification)</tradeName>
    <deviceName>Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0128</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:28.769Z</lastUpdated>
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  <row>
    <udiDi>06974674891834</udiDi>
    <basicUdiDi>B-06974674891834</basicUdiDi>
    <tradeName>2019-nCoV Nucleic acid Detection Kit (Real Time PCR)</tradeName>
    <deviceName>2019-nCoV Nucleic acid Detection Kit (Real Time PCR)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0127</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:26.363Z</lastUpdated>
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  <row>
    <udiDi>06974674891827</udiDi>
    <basicUdiDi>B-06974674891827</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0126</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:24.766Z</lastUpdated>
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  <row>
    <udiDi>06974674891810</udiDi>
    <basicUdiDi>B-06974674891810</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0135</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:23.968Z</lastUpdated>
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  <row>
    <udiDi>06974674891803</udiDi>
    <basicUdiDi>B-06974674891803</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0134</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:22.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891797</udiDi>
    <basicUdiDi>B-06974674891797</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:19.961Z</lastUpdated>
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  <row>
    <udiDi>06974674891780</udiDi>
    <basicUdiDi>B-06974674891780</basicUdiDi>
    <tradeName>Influenza A/B Virus Antigen Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Influenza A/B Virus Antigen Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0125</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:18.369Z</lastUpdated>
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  <row>
    <udiDi>06974674891773</udiDi>
    <basicUdiDi>B-06974674891773</basicUdiDi>
    <tradeName>Estradiol (E2) Detection Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Estradiol (E2) Detection Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0124</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:17.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891766</udiDi>
    <basicUdiDi>B-06974674891766</basicUdiDi>
    <tradeName>Ferritin(FERR) Detection Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Ferritin(FERR) Detection Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0123</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:15.966Z</lastUpdated>
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    <udiDi>06974674891759</udiDi>
    <basicUdiDi>B-06974674891759</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin (HbA1c) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0122</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:13.559Z</lastUpdated>
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    <udiDi>06974674891742</udiDi>
    <basicUdiDi>B-06974674891742</basicUdiDi>
    <tradeName>Myoglobin (MYO) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Myoglobin (MYO) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0121</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:12.645Z</lastUpdated>
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  <row>
    <udiDi>06974674891735</udiDi>
    <basicUdiDi>B-06974674891735</basicUdiDi>
    <tradeName>D-dimer Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>D-dimer Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:11.489Z</lastUpdated>
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    <udiDi>06974674891728</udiDi>
    <basicUdiDi>B-06974674891728</basicUdiDi>
    <tradeName>N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0119</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:09.575Z</lastUpdated>
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    <udiDi>06974674891711</udiDi>
    <basicUdiDi>B-06974674891711</basicUdiDi>
    <tradeName>Creatine Kinase Isoenzyme (CK-MB) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Creatine Kinase Isoenzyme (CK-MB) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0118</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:07.372Z</lastUpdated>
  </row>
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    <udiDi>06974674891704</udiDi>
    <basicUdiDi>B-06974674891704</basicUdiDi>
    <tradeName>Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0117</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:06.202Z</lastUpdated>
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