<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08806712906133</udiDi>
    <basicUdiDi>8806712POCECT004GZ</basicUdiDi>
    <tradeName>i-Smart 30 PRO Cartridge E4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCECT004-300T4W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:18.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195005601</udiDi>
    <basicUdiDi>4049195BMS8X00RN</basicUdiDi>
    <tradeName>ClinMass® Supplement Kit for Ethylglucuronide and Ethylsulfate in Plasma and Serum</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS8100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195005700</udiDi>
    <basicUdiDi>4049195BMS2X00QC</basicUdiDi>
    <tradeName>ClinSpot® Complete Kit for Homocysteine in Dried Blood Spots (DBS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS2100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195005892</udiDi>
    <basicUdiDi>4049195CMS10X00PS</basicUdiDi>
    <tradeName>ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)  with Filter-Plates</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010402</emdnCode>
    <emdnDescription>MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS10100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195006882</udiDi>
    <basicUdiDi>4049195CMS10X00PS</basicUdiDi>
    <tradeName>ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS),  non-derivatised</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010402</emdnCode>
    <emdnDescription>MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS10200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195006943</udiDi>
    <basicUdiDi>4049195CMS10X00PS</basicUdiDi>
    <tradeName>ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)  with Filter-Plates, non-derivatised</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010402</emdnCode>
    <emdnDescription>MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS10300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195007070</udiDi>
    <basicUdiDi>4049195BMS11X00PE</basicUdiDi>
    <tradeName>ClinMass® Complete Kit for Free Metanephrines in Plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS11100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195007490</udiDi>
    <basicUdiDi>4049195BMS7X00RF</basicUdiDi>
    <tradeName>ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum AUTOMATED  ON-LINE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS7100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195007506</udiDi>
    <basicUdiDi>4049195BMS7X00RF</basicUdiDi>
    <tradeName>ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum AUTOMATED  ON-LINE  with Filter-Plates</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS7200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:59.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195007513</udiDi>
    <basicUdiDi>4049195CMS1X00MS992009A</basicUdiDi>
    <tradeName>ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood AUTOMATED ON-LINE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195007520</udiDi>
    <basicUdiDi>4049195CMS1X00MS992009A</basicUdiDi>
    <tradeName>ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood AUTOMATED ON-LINE  with Filter-Plates</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS1300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195007544</udiDi>
    <basicUdiDi>4049195CMS1X00MS992009A</basicUdiDi>
    <tradeName>ClinMass® Add-on Set for Immunosuppressants in Whole Blood</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS99200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195020000</udiDi>
    <basicUdiDi>4049195B1000-6000FQ</basicUdiDi>
    <tradeName>ClinRep® Complete Kit for Catecholamines in Urine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195035004</udiDi>
    <basicUdiDi>4049195B1000-6000FQ</basicUdiDi>
    <tradeName>ClinRep®  Complete Kit for VMA, HVA, 5-HIAA in Urine, advanced</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195045003</udiDi>
    <basicUdiDi>4049195B1000-6000FQ</basicUdiDi>
    <tradeName>ClinRep® Complete Kit for Metanephrines in Urine, advanced</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195141002</udiDi>
    <basicUdiDi>4049195C14X00BL</basicUdiDi>
    <tradeName>ClinRep® Complete Kit for Antiepileptics in Serum / Plasma by UHPLC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195211002</udiDi>
    <basicUdiDi>4049195B21X00AV</basicUdiDi>
    <tradeName>ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum ON-LINE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195212009</udiDi>
    <basicUdiDi>4049195B21X00AV</basicUdiDi>
    <tradeName>ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum AUTOMATED ON-LINE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195221001</udiDi>
    <basicUdiDi>4049195B22X00B4</basicUdiDi>
    <tradeName>ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma by UHPLC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049195250001</udiDi>
    <basicUdiDi>4049195B24000-27000NG</basicUdiDi>
    <tradeName>ClinRep® Complete Kit for Vitamin B2 in Whole Blood</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:59:58.413Z</lastUpdated>
  </row>
</eudamedExport>