<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH01062105K</udiDi>
    <basicUdiDi>B-ECH01062105K</basicUdiDi>
    <tradeName>D-ECH01062105K</tradeName>
    <deviceName>Creatine Kinase (CK)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0106210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:41.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01052105C</udiDi>
    <basicUdiDi>B-ECH01052105C</basicUdiDi>
    <tradeName>D-ECH01052105C</tradeName>
    <deviceName>Creatine Kinase (CK)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:45.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01012104G</udiDi>
    <basicUdiDi>B-ECH01012104G</basicUdiDi>
    <tradeName>D-ECH01012104G</tradeName>
    <deviceName>Creatine Kinase (CK)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:19.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CreatineKinase-VC</udiDi>
    <basicUdiDi>B-CreatineKinase-VC</basicUdiDi>
    <tradeName>Creatine kinase</tradeName>
    <deviceName>Creatine kinase</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Ck-Mk-0520</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:28.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK601SA</udiDi>
    <basicUdiDi>B-CK601SA</basicUdiDi>
    <tradeName>Creatine Kinase Reagent Kit</tradeName>
    <deviceName>Creatine Kinase Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK6011Y, CK6012Y, CK6013Y, CK6014Y, CK6015Y, CK6011N, CK6012N, CK6013N, CK6014N, CK6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:43.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-NAC-LRWY</udiDi>
    <basicUdiDi>B-CK-NAC-LRWY</basicUdiDi>
    <tradeName>D-CK-NAC-LRWY</tradeName>
    <deviceName>CK NAC LR Reagente liquido</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC253-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:42.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0173LL</udiDi>
    <basicUdiDi>B-C0173LL</basicUdiDi>
    <tradeName>CK NAC</tradeName>
    <deviceName>CK NAC</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0173</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:32.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77940K5</udiDi>
    <basicUdiDi>B-77940K5</basicUdiDi>
    <tradeName>SPOTCHEM D CK</tradeName>
    <deviceName>SPOTCHEM D CK</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:24:35.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77407JE</udiDi>
    <basicUdiDi>B-77407JE</basicUdiDi>
    <tradeName>SPOTCHEM II CPK</tradeName>
    <deviceName>SPOTCHEM II CPK</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77407</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:16.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77172JA</udiDi>
    <basicUdiDi>B-77172JA</basicUdiDi>
    <tradeName>SPOTCHEM II CPK</tradeName>
    <deviceName>SPOTCHEM II CPK</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77172</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:44.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-476836RX</udiDi>
    <basicUdiDi>B-476836RX</basicUdiDi>
    <tradeName>Creatine Kinase Reagent</tradeName>
    <deviceName>Creatine Kinase Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>476836</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:07:37.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467830RF</udiDi>
    <basicUdiDi>B-467830RF</basicUdiDi>
    <tradeName>Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200)</tradeName>
    <deviceName>Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467830</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:12.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-442635PN</udiDi>
    <basicUdiDi>B-442635PN</basicUdiDi>
    <tradeName>Creatine Kinase Reagent</tradeName>
    <deviceName>Creatine Kinase Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442635</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:45:54.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490586TM</udiDi>
    <basicUdiDi>B-4260152490586TM</basicUdiDi>
    <tradeName>Creatinkinase aus Serum/Plasma</tradeName>
    <deviceName>DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK 121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:18:19.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490074SM</udiDi>
    <basicUdiDi>B-4260152490074SM</basicUdiDi>
    <tradeName>Creatine Kinase</tradeName>
    <deviceName>DP 350 / DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK 321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:33.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-107H50TSC45</udiDi>
    <basicUdiDi>B-107H50TSC45</basicUdiDi>
    <tradeName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</tradeName>
    <deviceName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:08.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-107H50T4M</udiDi>
    <basicUdiDi>B-107H50T4M</basicUdiDi>
    <tradeName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</tradeName>
    <deviceName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107H50T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:07.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-107H240TSCKV</udiDi>
    <basicUdiDi>B-107H240TSCKV</basicUdiDi>
    <tradeName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</tradeName>
    <deviceName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107H240TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:04.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-107H240TFZ</udiDi>
    <basicUdiDi>B-107H240TFZ</basicUdiDi>
    <tradeName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</tradeName>
    <deviceName>Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107H240T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:02.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1076P</udiDi>
    <basicUdiDi>B-1076P</basicUdiDi>
    <tradeName>D-1076P</tradeName>
    <deviceName>Creatine Kinase Kit (NAC Method)</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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:17:57.599Z</lastUpdated>
  </row>
</eudamedExport>