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<eudamedExport entity="devices">
  <row>
    <udiDi>03770024321425</udiDi>
    <basicUdiDi>B-03770024321425</basicUdiDi>
    <tradeName>RIA-gnost PIIIP</tradeName>
    <deviceName>OCFK07-PIIIP</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCFK07-PIIIP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:32:30.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236156</udiDi>
    <basicUdiDi>697846523OtherB03YS</basicUdiDi>
    <tradeName>Hyaluronic Acid Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Hyaluronic Acid 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120103</emdnCode>
    <emdnDescription>HYALURONIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:12.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465235609</udiDi>
    <basicUdiDi>697846523ProteinB09RQ</basicUdiDi>
    <tradeName>Collagen Type IV Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Collagen Type IV 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:00.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900564</udiDi>
    <basicUdiDi>69449040004S-C4********6S</basicUdiDi>
    <tradeName>Collagen Type IV (CLIA)</tradeName>
    <deviceName>Collagen Type IV (CLIA)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010718-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:12.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900540</udiDi>
    <basicUdiDi>69449040004S-PIIINP****VT</basicUdiDi>
    <tradeName>N-terminal Peptide of Procollagen Type III (CLIA)</tradeName>
    <deviceName>N-terminal Peptide of Procollagen Type III (CLIA)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010717-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:11.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900526</udiDi>
    <basicUdiDi>69449040004S-HA********KX</basicUdiDi>
    <tradeName>Hyaluronic acid (CLIA)</tradeName>
    <deviceName>Hyaluronic acid (CLIA)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120103</emdnCode>
    <emdnDescription>HYALURONIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010716-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:10.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900502</udiDi>
    <basicUdiDi>69449040004S-LN********YW</basicUdiDi>
    <tradeName>Laminin (CLIA)</tradeName>
    <deviceName>Laminin (CLIA)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010715-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:09.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133050750</udiDi>
    <basicUdiDi>880613300653CN</basicUdiDi>
    <tradeName>AFIAS sphingotest® penKid®</tradeName>
    <deviceName>AFIAS sphingotest® penKid®</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021299</emdnCode>
    <emdnDescription>ORGAN FUNCTION ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-156-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:38:40.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133045206</udiDi>
    <basicUdiDi>880613300653CN</basicUdiDi>
    <tradeName>AFIAS sphingotest® penKid®</tradeName>
    <deviceName>AFIAS sphingotest® penKid®</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021299</emdnCode>
    <emdnDescription>ORGAN FUNCTION ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-156</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:38:27.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341688110</udiDi>
    <basicUdiDi>B-06970341688110</basicUdiDi>
    <tradeName>Procollagen III N-terminal peptide (PIIINP) eCLIA</tradeName>
    <deviceName>Procollagen III N-terminal peptide (PIIINP) 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>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:21.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341688004</udiDi>
    <basicUdiDi>B-06970341688004</basicUdiDi>
    <tradeName>Cholylglycine (CG) eCLIA</tradeName>
    <deviceName>Cholylglycine (CG) 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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:52.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341687991</udiDi>
    <basicUdiDi>B-06970341687991</basicUdiDi>
    <tradeName>Collagen Type IV (CIV) eCLIA</tradeName>
    <deviceName>Collagen Type IV (CIV) 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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:49.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685669</udiDi>
    <basicUdiDi>B-06970341685669</basicUdiDi>
    <tradeName>Procollagen III N-terminal peptide (PIIINP) eCLIA</tradeName>
    <deviceName>Procollagen III N-terminal peptide (PIIINP) 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>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:15.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685652</udiDi>
    <basicUdiDi>B-06970341685652</basicUdiDi>
    <tradeName>Procollagen III N-terminal peptide (PIIINP) eCLIA</tradeName>
    <deviceName>Procollagen III N-terminal peptide (PIIINP) 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>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:13.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685621</udiDi>
    <basicUdiDi>B-06970341685621</basicUdiDi>
    <tradeName>Cholylglycine (CG) eCLIA</tradeName>
    <deviceName>Cholylglycine (CG) 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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:05.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685614</udiDi>
    <basicUdiDi>B-06970341685614</basicUdiDi>
    <tradeName>Cholylglycine (CG) eCLIA</tradeName>
    <deviceName>Cholylglycine (CG) 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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:03.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685607</udiDi>
    <basicUdiDi>B-06970341685607</basicUdiDi>
    <tradeName>Collagen Type IV (CIV) eCLIA</tradeName>
    <deviceName>Collagen Type IV (CIV) 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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:57:02.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341685591</udiDi>
    <basicUdiDi>B-06970341685591</basicUdiDi>
    <tradeName>Collagen Type IV (CIV) eCLIA</tradeName>
    <deviceName>Collagen Type IV (CIV) 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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:56:59.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414798524</udiDi>
    <basicUdiDi>B-06954414798524</basicUdiDi>
    <tradeName>Getein</tradeName>
    <deviceName>MAGICL CG (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:46.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414798517</udiDi>
    <basicUdiDi>B-06954414798517</basicUdiDi>
    <tradeName>MAGICL HA (CLIA)</tradeName>
    <deviceName>MAGICL HA (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120103</emdnCode>
    <emdnDescription>HYALURONIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:45.707Z</lastUpdated>
  </row>
</eudamedExport>