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<eudamedExport entity="devices">
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    <basicUdiDi>B-06952804817145</basicUdiDi>
    <tradeName>Methylphenidate</tradeName>
    <deviceName>Methylphenidate</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPD-U11 MPD-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:37.316Z</lastUpdated>
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  <row>
    <udiDi>06952804817121</udiDi>
    <basicUdiDi>B-06952804817121</basicUdiDi>
    <tradeName>Carisopodol  (SOMA)  Rapid Test</tradeName>
    <deviceName>Carisopodol  (SOMA)  Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-U11 CAR-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:31.315Z</lastUpdated>
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  <row>
    <udiDi>06952804817060</udiDi>
    <basicUdiDi>B-06952804817060</basicUdiDi>
    <tradeName>Tropicamide Rapid Test</tradeName>
    <deviceName>Tropicamide Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPM-U11 TPM-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:22.913Z</lastUpdated>
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  <row>
    <udiDi>06952804817046</udiDi>
    <basicUdiDi>B-06952804817046</basicUdiDi>
    <tradeName>Alprazolam Rapid Test</tradeName>
    <deviceName>Alprazolam Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALP-U11 ALP-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:20.846Z</lastUpdated>
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  <row>
    <udiDi>06952804816889</udiDi>
    <basicUdiDi>B-06952804816889</basicUdiDi>
    <tradeName>Caffeine Rapid Test</tradeName>
    <deviceName>Caffeine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080401</emdnCode>
    <emdnDescription>CAFFEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAF-U11 CAF-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:00.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816865</udiDi>
    <basicUdiDi>B-06952804816865</basicUdiDi>
    <tradeName>Zopiclone Rapid Test</tradeName>
    <deviceName>Zopiclone Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZOP-U11 ZOP-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:59.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816827</udiDi>
    <basicUdiDi>B-06952804816827</basicUdiDi>
    <tradeName>Gabapentin Rapid Test</tradeName>
    <deviceName>Gabapentin Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080211</emdnCode>
    <emdnDescription>GABAPENTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAB-U11 GAB-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:51.697Z</lastUpdated>
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  <row>
    <udiDi>06947145502157</udiDi>
    <basicUdiDi>B-06947145502157</basicUdiDi>
    <tradeName>MAGLUMI FK 506 (CLIA)</tradeName>
    <deviceName>FK 506 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130207003M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:45.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501457</udiDi>
    <basicUdiDi>B-06947145501457</basicUdiDi>
    <tradeName>MAGLUMI CSA (CLIA)</tradeName>
    <deviceName>CSA (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130207001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:33.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770029302030</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Mobile Phase B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40103-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770029302047</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>System Cleaning Phase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40104-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.444Z</lastUpdated>
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  <row>
    <udiDi>03770029302054</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Extraction Buffer (IM-M)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40105-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.425Z</lastUpdated>
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  <row>
    <udiDi>03770029302061</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Internal Standard Set (IM-M)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40106-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.411Z</lastUpdated>
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  <row>
    <udiDi>03770029302078</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Calibrator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40120-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:14.379Z</lastUpdated>
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  <row>
    <udiDi>03770029302085</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40110-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.108Z</lastUpdated>
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  <row>
    <udiDi>03770029302092</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Column Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40142-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.089Z</lastUpdated>
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    <udiDi>03770029302122</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>PACK 1400</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40190-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.074Z</lastUpdated>
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    <udiDi>03770029302139</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>PACK 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40180-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.058Z</lastUpdated>
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    <udiDi>03770029302146</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Internal Standard Set (IM-A)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-40175-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.046Z</lastUpdated>
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    <udiDi>03770029302153</udiDi>
    <basicUdiDi>3770029302IMK00TU</basicUdiDi>
    <tradeName>Extraction Buffer (IM-A)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHIMADZU CHEMISTRY AND DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000048960</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-41085-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:56.031Z</lastUpdated>
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