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<eudamedExport entity="devices">
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    <udiDi>06933289857529</udiDi>
    <basicUdiDi>B-06933289857529</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>B-type Natriuretic Peptide (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</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>W382P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:51.082Z</lastUpdated>
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  <row>
    <udiDi>06933289857512</udiDi>
    <basicUdiDi>B-06933289857512</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W381P0007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:49.472Z</lastUpdated>
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  <row>
    <udiDi>06933289857505</udiDi>
    <basicUdiDi>B-06933289857505</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W381P0006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:48.674Z</lastUpdated>
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  <row>
    <udiDi>06933289857499</udiDi>
    <basicUdiDi>B-06933289857499</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W381P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:47.066Z</lastUpdated>
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  <row>
    <udiDi>06933289857482</udiDi>
    <basicUdiDi>B-06933289857482</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W381P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:44.673Z</lastUpdated>
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  <row>
    <udiDi>06933289849920</udiDi>
    <basicUdiDi>B-06933289849920</basicUdiDi>
    <tradeName>U-Card™ 200</tradeName>
    <deviceName>2019-nCoV/Flu/RSV Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR38P0006</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:38.271Z</lastUpdated>
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  <row>
    <udiDi>06933289849913</udiDi>
    <basicUdiDi>B-06933289849913</basicUdiDi>
    <tradeName>U-Card™ 200</tradeName>
    <deviceName>2019-nCoV/Flu/RSV Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR38P0005</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:36.666Z</lastUpdated>
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  <row>
    <udiDi>06933289849906</udiDi>
    <basicUdiDi>B-06933289849906</basicUdiDi>
    <tradeName>U-Card™ 200</tradeName>
    <deviceName>2019-nCoV/Flu/RSV Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR38P0004</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:05:35.861Z</lastUpdated>
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  <row>
    <udiDi>06933289850506</udiDi>
    <basicUdiDi>69332898CE3186FW</basicUdiDi>
    <tradeName>U-CardDxTM 200</tradeName>
    <deviceName>Automated Rapid Molecular Diagnostic System</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WK46</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:07:56.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289850513</udiDi>
    <basicUdiDi>69332898CE3186FW</basicUdiDi>
    <tradeName>U-CardDxTM 200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WK47</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:37.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289850520</udiDi>
    <basicUdiDi>69332898CE3186FW</basicUdiDi>
    <tradeName>U-CardDxTM 200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WK48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:36.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289850537</udiDi>
    <basicUdiDi>69332898CE3186FW</basicUdiDi>
    <tradeName>U-CardDxTM 200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WK49</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:36.299Z</lastUpdated>
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  <row>
    <udiDi>06933289852951</udiDi>
    <basicUdiDi>B-06933289852951</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Inhibin B (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA13P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:48.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289852944</udiDi>
    <basicUdiDi>B-06933289852944</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Inhibin B (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA13P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:44.536Z</lastUpdated>
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  <row>
    <udiDi>06933289852937</udiDi>
    <basicUdiDi>B-06933289852937</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Inhibin B (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA13P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:43.738Z</lastUpdated>
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  <row>
    <udiDi>06933289852920</udiDi>
    <basicUdiDi>B-06933289852920</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Inhibin B (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA13P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:42.935Z</lastUpdated>
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    <udiDi>06933289852876</udiDi>
    <basicUdiDi>B-06933289852876</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Prolactin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA63P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:42.134Z</lastUpdated>
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  <row>
    <udiDi>06933289852869</udiDi>
    <basicUdiDi>B-06933289852869</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Prolactin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA63P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:38.130Z</lastUpdated>
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    <udiDi>06933289852852</udiDi>
    <basicUdiDi>B-06933289852852</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Prolactin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA63P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:37.331Z</lastUpdated>
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  <row>
    <udiDi>06933289852845</udiDi>
    <basicUdiDi>B-06933289852845</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Prolactin (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA63P0001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:53:36.539Z</lastUpdated>
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