<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DE183239</udiDi>
    <basicUdiDi>B-DE183239</basicUdiDi>
    <tradeName>D-DE183239</tradeName>
    <deviceName>beta-Hydroxybutyrate, Enzymatic, UV</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE1832</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:31.488Z</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-COLINESTERASI-LRGV</udiDi>
    <basicUdiDi>B-COLINESTERASI-LRGV</basicUdiDi>
    <tradeName>COLINESTERASI LR Reattivo Liquido</tradeName>
    <deviceName>COLINESTERASI LR Reattivo 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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC205-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:51.740Z</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-CK-MB60175</udiDi>
    <basicUdiDi>B-CK-MB60175</basicUdiDi>
    <tradeName>Creatine Kinase MB Isoenzyme Reagent Kit</tradeName>
    <deviceName>Creatine Kinase MB Isoenzyme 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>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-MB6011Y, CK-MB6012Y, CK-MB6013Y, CK-MB6014Y, CK-MB6015Y, CK-MB6011N, CK-MB6012N, CK-MB6013N, CK-MB6014N, CK-MB6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:40.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CHE6017D</udiDi>
    <basicUdiDi>B-CHE6017D</basicUdiDi>
    <tradeName>Cholinesterase Reagent Kit</tradeName>
    <deviceName>Cholinesterase 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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHE6011Y, CHE6012Y, CHE6013Y, CHE6014Y, CHE6015Y, CHE6011N, CHE6012N, CHE6013N, CHE6014N, CHE6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:05:21.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0297M7</udiDi>
    <basicUdiDi>B-C0297M7</basicUdiDi>
    <tradeName>LIPASE COLOR ONE</tradeName>
    <deviceName>LIPASE COLOR ONE</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>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0297</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:50:16.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0272LP</udiDi>
    <basicUdiDi>B-C0272LP</basicUdiDi>
    <tradeName>CK MB</tradeName>
    <deviceName>CK MB</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>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0173</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:50:10.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0257LT</udiDi>
    <basicUdiDi>B-C0257LT</basicUdiDi>
    <tradeName>Acid Prostatic Phosphatase</tradeName>
    <deviceName>Acid Prostatic Phosphatase</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>W01010102</emdnCode>
    <emdnDescription>ACID PHOSPHATASE (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0257</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:50:09.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0183LP</udiDi>
    <basicUdiDi>B-C0183LP</basicUdiDi>
    <tradeName>LDH (Lactate Dehydrogenase)</tradeName>
    <deviceName>LDH (Lactate Dehydrogenase)</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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0183</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:39.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0178LW</udiDi>
    <basicUdiDi>B-C0178LW</basicUdiDi>
    <tradeName>γ‐GT (GAMMA GT)</tradeName>
    <deviceName>γ‐GT (GAMMA GT)</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>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0178</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:36.685Z</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-C0169LV</udiDi>
    <basicUdiDi>B-C0169LV</basicUdiDi>
    <tradeName>Cholinesterase</tradeName>
    <deviceName>Cholinesterase</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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0169</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:30.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0163LH</udiDi>
    <basicUdiDi>B-C0163LH</basicUdiDi>
    <tradeName>aminotransferase</tradeName>
    <deviceName>AST (GOT)</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>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0163</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:21.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0162LF</udiDi>
    <basicUdiDi>B-C0162LF</basicUdiDi>
    <tradeName>Alkaline Phosphatase</tradeName>
    <deviceName>Alkaline Phosphatase</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>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0162</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:19.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0160LB</udiDi>
    <basicUdiDi>B-C0160LB</basicUdiDi>
    <tradeName>Amylase</tradeName>
    <deviceName>Amylase</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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0160</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:19.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0158LQ</udiDi>
    <basicUdiDi>B-C0158LQ</basicUdiDi>
    <tradeName>ALT (GPT)</tradeName>
    <deviceName>ALT (GPT)</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>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0158</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:15.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AmylaseAX</udiDi>
    <basicUdiDi>B-AmylaseAX</basicUdiDi>
    <tradeName>Amylase</tradeName>
    <deviceName>Amylase</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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>(Amy-Mk-100)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:00.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AlkalinePhosphatase6K</udiDi>
    <basicUdiDi>B-AlkalinePhosphatase6K</basicUdiDi>
    <tradeName>Alkaline Phosphates</tradeName>
    <deviceName>Alkaline phosphatase</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>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Alp-Mk-0420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:45:55.408Z</lastUpdated>
  </row>
</eudamedExport>