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<eudamedExport entity="devices">
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    <udiDi>06976753470374</udiDi>
    <basicUdiDi>B-06976753470374</basicUdiDi>
    <tradeName>Carbohydrate antigen 50 Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:12.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470336</udiDi>
    <basicUdiDi>B-06976753470336</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (Beta2-MG) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:11.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470299</udiDi>
    <basicUdiDi>B-06976753470299</basicUdiDi>
    <tradeName>Pro-Gastrin Releasing Peptide (ProGRP) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:11.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470251</udiDi>
    <basicUdiDi>B-06976753470251</basicUdiDi>
    <tradeName>Squamous Cell Carcinoma Antigen (SCCA) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:27.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470213</udiDi>
    <basicUdiDi>B-06976753470213</basicUdiDi>
    <tradeName>Progesterone Receptor (PR) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030202</emdnCode>
    <emdnDescription>PROGESTERONE RECEPTOR ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:26.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470091</udiDi>
    <basicUdiDi>B-06976753470091</basicUdiDi>
    <tradeName>Neuron-Specific Enolase (NSE) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2H003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:22.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470053</udiDi>
    <basicUdiDi>B-06976753470053</basicUdiDi>
    <tradeName>CYFRA 21-1 Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:21.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753470015</udiDi>
    <basicUdiDi>B-06976753470015</basicUdiDi>
    <tradeName>Human Epididymis Protein 4 (HE4) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:18.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976045540082</udiDi>
    <basicUdiDi>B-06976045540082</basicUdiDi>
    <tradeName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:24.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976045540075</udiDi>
    <basicUdiDi>B-06976045540075</basicUdiDi>
    <tradeName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:24.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976045540068</udiDi>
    <basicUdiDi>B-06976045540068</basicUdiDi>
    <tradeName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:23.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976045540051</udiDi>
    <basicUdiDi>B-06976045540051</basicUdiDi>
    <tradeName>06976045540051</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:22.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976045540044</udiDi>
    <basicUdiDi>B-06976045540044</basicUdiDi>
    <tradeName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Colloidal Gold method)</deviceName>
    <manufacturerName>Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055042</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:17.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976043630136</udiDi>
    <basicUdiDi>B-06976043630136</basicUdiDi>
    <tradeName>06976043630136</tradeName>
    <deviceName>CEA Assay Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:26:49.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984064437</udiDi>
    <basicUdiDi>B-06975984064437</basicUdiDi>
    <tradeName>Alpha-Fetoprotein (eCLIA)</tradeName>
    <deviceName>Alpha-Fetoprotein (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:33.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984064383</udiDi>
    <basicUdiDi>B-06975984064383</basicUdiDi>
    <tradeName>CA50 (eCLIA)</tradeName>
    <deviceName>CA50 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:25.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984064369</udiDi>
    <basicUdiDi>B-06975984064369</basicUdiDi>
    <tradeName>CA50 (eCLIA)</tradeName>
    <deviceName>CA50 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:24.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984064345</udiDi>
    <basicUdiDi>B-06975984064345</basicUdiDi>
    <tradeName>CA242 (eCLIA)</tradeName>
    <deviceName>CA242 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510704</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:19.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984064321</udiDi>
    <basicUdiDi>B-06975984064321</basicUdiDi>
    <tradeName>CA242 (eCLIA)</tradeName>
    <deviceName>CA242 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:18.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063683</udiDi>
    <basicUdiDi>B-06975984063683</basicUdiDi>
    <tradeName>Laminin (LN) eCLIA</tradeName>
    <deviceName>Laminin (LN) eCLIA</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039006</emdnCode>
    <emdnDescription>LAMININ</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:19:53.794Z</lastUpdated>
  </row>
</eudamedExport>