<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A037D6</udiDi>
    <basicUdiDi>B-A037D6</basicUdiDi>
    <tradeName>INDICAID™ Lactose Intolerance Test</tradeName>
    <deviceName>INDICAID™ Lactose Intolerance Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010212</emdnCode>
    <emdnDescription>GALACTOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Lactose Intolerance Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:41:47.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975808410129</udiDi>
    <basicUdiDi>B-06975808410129</basicUdiDi>
    <tradeName>06975808410129</tradeName>
    <deviceName>Galactose Test Kit (Enzyme Chemical Reaction Method)</deviceName>
    <manufacturerName>Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044320</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010212</emdnCode>
    <emdnDescription>GALACTOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:11:52.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735361887</udiDi>
    <basicUdiDi>B-06974735361887</basicUdiDi>
    <tradeName>KEYU Lactose Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Lactose Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010212</emdnCode>
    <emdnDescription>GALACTOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAC-II</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:19.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735361870</udiDi>
    <basicUdiDi>B-06974735361870</basicUdiDi>
    <tradeName>KEYU Lactose Assay Kit (Enzymatic Method)</tradeName>
    <deviceName>Lactose Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010212</emdnCode>
    <emdnDescription>GALACTOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAC-I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:19.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438172219014</udiDi>
    <basicUdiDi>B-06438172219014</basicUdiDi>
    <tradeName>Neonatal GALT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010212</emdnCode>
    <emdnDescription>GALACTOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6199810</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:25.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438172162013</udiDi>
    <basicUdiDi>B-06438172162013</basicUdiDi>
    <tradeName>Neonatal Galactose</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010212</emdnCode>
    <emdnDescription>GALACTOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6199850</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:06.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147367900</udiDi>
    <basicUdiDi>B-06438147367900</basicUdiDi>
    <tradeName>GSP Neonatal Total Galactose kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010212</emdnCode>
    <emdnDescription>GALACTOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3309-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:36:55.163Z</lastUpdated>
  </row>
</eudamedExport>