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<eudamedExport entity="devices">
  <row>
    <udiDi>D-MS9700CW</udiDi>
    <basicUdiDi>B-MS9700CW</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Antibiotics in Serum / Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS9700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:39.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MFG030062QU</udiDi>
    <basicUdiDi>B-MFG030062QU</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>ALC-MS/MS Kit for the quantitative measurement of antibiotics in serum</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030062</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:06:52.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753476086</udiDi>
    <basicUdiDi>B-06976753476086</basicUdiDi>
    <tradeName>Human Monkeypox Virus (MPV) IgGIgM Antibody Rapid Test Device（Colloidal Gold)</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>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A060501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:54.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753476055</udiDi>
    <basicUdiDi>B-06976753476055</basicUdiDi>
    <tradeName>Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)</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>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A051601D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:50.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753472958</udiDi>
    <basicUdiDi>B-06976753472958</basicUdiDi>
    <tradeName>SARS-Cov-2＆ FLU A&amp;B &amp; RSV &amp; Adv Combo Rapid Test Cassett(swab)</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>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A141301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:18.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753472651</udiDi>
    <basicUdiDi>B-06976753472651</basicUdiDi>
    <tradeName>Respiratory Syncytial Viral Rapid Test Device  (Swab)</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>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A081301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:04.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003223</udiDi>
    <basicUdiDi>B-00858724003223</basicUdiDi>
    <tradeName>ARK Voriconazole II Assay</tradeName>
    <deviceName>ARK Voriconazole II Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5030-0001-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:59.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590698</udiDi>
    <basicUdiDi>697518250F1142022</basicUdiDi>
    <tradeName>Polymyxin B CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Polymyxin B CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11420</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:03.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590629</udiDi>
    <basicUdiDi>697518250F1141325</basicUdiDi>
    <tradeName>Meropenem CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Meropenem CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11413</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:44.996Z</lastUpdated>
  </row>
</eudamedExport>