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<eudamedExport entity="devices">
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    <udiDi>05055273218985</udiDi>
    <basicUdiDi>50552732CCELISA0649X</basicUdiDi>
    <tradeName>ConcizuTrace™ ELISA</tradeName>
    <deviceName>ConcizuTrace™ ELISA</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CZM10591</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:35.248Z</lastUpdated>
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    <udiDi>03770024131079</udiDi>
    <basicUdiDi>3770024131INF-ADAX3</basicUdiDi>
    <tradeName>mAbXmise IADA1</tradeName>
    <deviceName>mAbXmise – Anti-drug antibodies quantification  Kit multiplex ANTI-Infliximab &amp; ANTI-Adalimumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IADA1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:44.364Z</lastUpdated>
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    <udiDi>03770024131055</udiDi>
    <basicUdiDi>3770024131PNH-TDM7A</basicUdiDi>
    <tradeName>mAbXmise PNHTDM</tradeName>
    <deviceName>mAbXmise – Monoclonal antibodies quantification  Kit Eculizumab or Ravulizumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNHTDM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:43.579Z</lastUpdated>
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    <udiDi>03770024131048</udiDi>
    <basicUdiDi>3770024131HEM-TDMYZ</basicUdiDi>
    <tradeName>mAbXmise HTDM</tradeName>
    <deviceName>mAbXmise – Monoclonal antibody quantification  Kit Emicizumab</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HTDM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:57:42.760Z</lastUpdated>
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  <row>
    <udiDi>03770024131031</udiDi>
    <basicUdiDi>B-03770024131031</basicUdiDi>
    <tradeName>mAbXmise GTDM</tradeName>
    <deviceName>mAbXmise – Quantification kit Belatacept or Abatacept</deviceName>
    <manufacturerName>Promise proteomics</manufacturerName>
    <manufacturerSrn>FR-MF-000027377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTDM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T17:47:33.748Z</lastUpdated>
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  <row>
    <udiDi>06942293591503</udiDi>
    <basicUdiDi>697518250F114392P</basicUdiDi>
    <tradeName>Trastuzumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Trastuzumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11439-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:07:41.098Z</lastUpdated>
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    <udiDi>06942293552108</udiDi>
    <basicUdiDi>697518250F114382M</basicUdiDi>
    <tradeName>Free Anti-Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti-Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11438-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:07:14.639Z</lastUpdated>
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  <row>
    <udiDi>06942293552092</udiDi>
    <basicUdiDi>697518250F114372K</basicUdiDi>
    <tradeName>Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11437-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:07:13.849Z</lastUpdated>
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  <row>
    <udiDi>D-MS9600CR</udiDi>
    <basicUdiDi>B-MS9600CR</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Antimycotics 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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS9600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:37.905Z</lastUpdated>
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  <row>
    <udiDi>D-MS9000BT</udiDi>
    <basicUdiDi>B-MS9000BT</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® TDM Platform</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS9000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:28.253Z</lastUpdated>
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  <row>
    <udiDi>D-MS9000ASG</udiDi>
    <basicUdiDi>B-MS9000ASG</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® TDM Platform</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS9000A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:28.164Z</lastUpdated>
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  <row>
    <udiDi>D-FRMF000041783ONCOGRAMPA</udiDi>
    <basicUdiDi>B-FRMF000041783ONCOGRAMPA</basicUdiDi>
    <tradeName>Oncogramme</tradeName>
    <deviceName>Oncogramme for Colon</deviceName>
    <manufacturerName>Oncomedics SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000041783</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONCOGRAM2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:46:45.725Z</lastUpdated>
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  <row>
    <udiDi>06978945081221</udiDi>
    <basicUdiDi>B-06978945081221</basicUdiDi>
    <tradeName>Voriconazole Kit(LC-MS/MS)</tradeName>
    <deviceName>Voriconazole Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZP908A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:13.815Z</lastUpdated>
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  <row>
    <udiDi>06978945081191</udiDi>
    <basicUdiDi>B-06978945081191</basicUdiDi>
    <tradeName>Clozapine/Aripiprazole/Risperidone/ Olanzapine Kit(LC-MS/MS)</tradeName>
    <deviceName>Clozapine/Aripiprazole/Risperidone/ Olanzapine Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZP910A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:07.218Z</lastUpdated>
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    <udiDi>29418000012cxEXP</udiDi>
    <basicUdiDi>232118324ARRAYSZK</basicUdiDi>
    <tradeName>INDITREAT CRC EXPLORE ARRAY</tradeName>
    <deviceName>IndiTreat® ARRAYS</deviceName>
    <manufacturerName>2cureX A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000036335</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2CX-CRCEXP-01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:09:48.842Z</lastUpdated>
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    <udiDi>06952804817510</udiDi>
    <basicUdiDi>B-06952804817510</basicUdiDi>
    <tradeName>Trazodone Rapid Test</tradeName>
    <deviceName>Trazodone 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>TZD-U11 TZD-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:24.545Z</lastUpdated>
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    <udiDi>06952804817343</udiDi>
    <basicUdiDi>B-06952804817343</basicUdiDi>
    <tradeName>Zolpidem</tradeName>
    <deviceName>Zolpidem</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>ZOL-U11, ZOL-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:01.336Z</lastUpdated>
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    <udiDi>06952804817145</udiDi>
    <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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    <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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    <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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