<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00817238010042</udiDi>
    <basicUdiDi>B-00817238010042</basicUdiDi>
    <tradeName>00817238010042</tradeName>
    <deviceName>Cardiac Marker Control VS</deviceName>
    <manufacturerName>Cliniqa Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023908</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91474</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:01:59.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273200096</udiDi>
    <basicUdiDi>50552732BALSCON005DZ</basicUdiDi>
    <tradeName>ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2)</tradeName>
    <deviceName>ALDOLASE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD5001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:06.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700818908</udiDi>
    <basicUdiDi>37017008CKMB056K</basicUdiDi>
    <tradeName>CK-MB CONTROL</tradeName>
    <deviceName>CK-MB CONTROL</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CKMB-0900</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:37.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673022624</udiDi>
    <basicUdiDi>B-08431673022624</basicUdiDi>
    <tradeName>CK-NAC / CK-MB CONTROL</tradeName>
    <deviceName>Creatine kinase (Total) / Creatine kinase-MB Control High/Low</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1002262</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:15:09.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673022600</udiDi>
    <basicUdiDi>B-08431673022600</basicUdiDi>
    <tradeName>CK-NAC / CK-MB CONTROL</tradeName>
    <deviceName>Creatine kinase (Total) / Creatine kinase-MB Control High</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1002260</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:15:08.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6297S</udiDi>
    <basicUdiDi>B-6297S</basicUdiDi>
    <tradeName>D-6297S</tradeName>
    <deviceName>Enzyme Multical Control</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:39:36.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-13A3</udiDi>
    <basicUdiDi>B-6-13A3</basicUdiDi>
    <tradeName>D-6-13A3</tradeName>
    <deviceName>Enzyme compound quality control products</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000707, USCA00000708, USCA00000709, USCA00000710"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:05.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700818915</udiDi>
    <basicUdiDi>37017008CKMB056K</basicUdiDi>
    <tradeName>CK-MB CONTROL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CKMB-1030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:18.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Q90100BFM</udiDi>
    <basicUdiDi>B-Q90100BFM</basicUdiDi>
    <tradeName>D-Q90100BFM</tradeName>
    <deviceName>Sialidase (SNA) Control</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:22:58.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Q90100AFK</udiDi>
    <basicUdiDi>B-Q90100AFK</basicUdiDi>
    <tradeName>D-Q90100AFK</tradeName>
    <deviceName>Vaginitis Multitest Control</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:22:57.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01982189L</udiDi>
    <basicUdiDi>B-ECH01982189L</basicUdiDi>
    <tradeName>D-ECH01982189L</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0198218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:38.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01972189D</udiDi>
    <basicUdiDi>B-ECH01972189D</basicUdiDi>
    <tradeName>D-ECH01972189D</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0197218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:37.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019621896</udiDi>
    <basicUdiDi>B-ECH019621896</basicUdiDi>
    <tradeName>D-ECH019621896</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0196218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:32.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01952188X</udiDi>
    <basicUdiDi>B-ECH01952188X</basicUdiDi>
    <tradeName>D-ECH01952188X</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0195218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:25.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01942188Q</udiDi>
    <basicUdiDi>B-ECH01942188Q</basicUdiDi>
    <tradeName>D-ECH01942188Q</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0194218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:17.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01932188H</udiDi>
    <basicUdiDi>B-ECH01932188H</basicUdiDi>
    <tradeName>D-ECH01932188H</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0193218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:04.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019320588</udiDi>
    <basicUdiDi>B-ECH019320588</basicUdiDi>
    <tradeName>D-ECH019320588</tradeName>
    <deviceName>α-L-Fucosidase (AFU) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0193205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:43.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01922188A</udiDi>
    <basicUdiDi>B-ECH01922188A</basicUdiDi>
    <tradeName>D-ECH01922188A</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0192218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:28.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01922057Z</udiDi>
    <basicUdiDi>B-ECH01922057Z</basicUdiDi>
    <tradeName>D-ECH01922057Z</tradeName>
    <deviceName>α-L-Fucosidase (AFU) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0192205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:27.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019220683</udiDi>
    <basicUdiDi>B-ECH019220683</basicUdiDi>
    <tradeName>D-ECH019220683</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0192206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:23.007Z</lastUpdated>
  </row>
</eudamedExport>