<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH01090536G</udiDi>
    <basicUdiDi>B-ECH01090536G</basicUdiDi>
    <tradeName>D-ECH01090536G</tradeName>
    <deviceName>Creatinine (Crea) Assay Kit by SAO Method</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0109053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:17.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01050535L</udiDi>
    <basicUdiDi>B-ECH01050535L</basicUdiDi>
    <tradeName>D-ECH01050535L</tradeName>
    <deviceName>Creatinine (Crea) Assay Kit by SAO Method</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:14.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010534Q</udiDi>
    <basicUdiDi>B-ECH01010534Q</basicUdiDi>
    <tradeName>D-ECH01010534Q</tradeName>
    <deviceName>Creatinine (Crea) Assay Kit by SAO Method</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:28.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CreatinineCE</udiDi>
    <basicUdiDi>B-CreatinineCE</basicUdiDi>
    <tradeName>Creatinine</tradeName>
    <deviceName>Creatinine</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CRE-Mc-02100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:30.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CREATININA-JAFFEJ2</udiDi>
    <basicUdiDi>B-CREATININA-JAFFEJ2</basicUdiDi>
    <tradeName>CREATININA JAFFE' LR</tradeName>
    <deviceName>CREATININA JAFFE' LR</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC206-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:20.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CREATININA-ENZIMATICAK7</udiDi>
    <basicUdiDi>B-CREATININA-ENZIMATICAK7</basicUdiDi>
    <tradeName>ENZYMATIC CREATININE LR</tradeName>
    <deviceName>Creatinina Enzimatica LR</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC207-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:17.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CRE-E601A7</udiDi>
    <basicUdiDi>B-CRE-E601A7</basicUdiDi>
    <tradeName>Creatinine Reagent Kit</tradeName>
    <deviceName>Creatinine 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRE-E6011Y, CRE-E6012Y, CRE-E6013Y, CRE-E6014Y, CRE-E6015Y, CRE-E6011N, CRE-E6012N, CRE-E6013N, CRE-E6014N, CRE-E6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:13.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0104KZ</udiDi>
    <basicUdiDi>B-C0104KZ</basicUdiDi>
    <tradeName>Creatinine Pap</tradeName>
    <deviceName>Creatinine Pap</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:11.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A60298UW</udiDi>
    <basicUdiDi>B-A60298UW</basicUdiDi>
    <tradeName>Enzymatic Creatinine Reagent (CR-E 2 x 200)</tradeName>
    <deviceName>Enzymatic Creatinine Reagent (CR-E 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A60298</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:42.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A40920U6</udiDi>
    <basicUdiDi>B-A40920U6</basicUdiDi>
    <tradeName>Creatinine Reagent (CR-S 2 x 300)</tradeName>
    <deviceName>Creatinine Reagent (CR-S 2 x 300)</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A40920</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:30.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77412J7</udiDi>
    <basicUdiDi>B-77412J7</basicUdiDi>
    <tradeName>SPOTCHEM II Creatinine</tradeName>
    <deviceName>SPOTCHEM II Creatinine</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77412</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:26.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77177JL</udiDi>
    <basicUdiDi>B-77177JL</basicUdiDi>
    <tradeName>SPOTCHEM II Creatinine</tradeName>
    <deviceName>SPOTCHEM II Creatinine</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77177</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:50.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-74H40TWR</udiDi>
    <basicUdiDi>B-74H40TWR</basicUdiDi>
    <tradeName>Creatinine (CRE) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Creatinine (CRE) Assay Kit (Enzymatic 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74H40T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:15.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-74H40TSCU7</udiDi>
    <basicUdiDi>B-74H40TSCU7</basicUdiDi>
    <tradeName>Creatinine (CRE) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Creatinine (CRE) Assay Kit (Enzymatic 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74H40TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:13.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-74H240TSCAF</udiDi>
    <basicUdiDi>B-74H240TSCAF</basicUdiDi>
    <tradeName>Creatinine (CRE) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Creatinine (CRE) Assay Kit (Enzymatic 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74H240TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:09.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-74H240TA7</udiDi>
    <basicUdiDi>B-74H240TA7</basicUdiDi>
    <tradeName>Creatinine (CRE) Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Creatinine (CRE) Assay Kit (Enzymatic 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74H240T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:08.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-472525QF</udiDi>
    <basicUdiDi>B-472525QF</basicUdiDi>
    <tradeName>SYNCHRON Systems Creatinine (CREm) Reagent</tradeName>
    <deviceName>SYNCHRON Systems Creatinine (CREm) 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472525</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:58:16.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490302SB</udiDi>
    <basicUdiDi>B-4260152490302SB</basicUdiDi>
    <tradeName>Kreatinin</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRE 121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:58.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14977</udiDi>
    <basicUdiDi>B-14977</basicUdiDi>
    <tradeName>D-14977</tradeName>
    <deviceName>Creatinine Kit (Sarcosine Oxidase –PAP 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:27:49.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105587N6</udiDi>
    <basicUdiDi>B-105587N6</basicUdiDi>
    <tradeName>The Lab 004 CRE</tradeName>
    <deviceName>The Lab 004 CRE</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105587</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:29.382Z</lastUpdated>
  </row>
</eudamedExport>