<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04580153781385</udiDi>
    <basicUdiDi>458015378CitrixSeriesJG</basicUdiDi>
    <tradeName>Citrix-50H</tradeName>
    <deviceName>Organic acid based Disinfectant for Hemodialysis Machine</deviceName>
    <manufacturerName>AMTEC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000001277</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>50H001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:00:35.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580153781361</udiDi>
    <basicUdiDi>458015378SanacideSeries57</basicUdiDi>
    <tradeName>Sanacide</tradeName>
    <deviceName>Peracetic acid based Disinfectant for Hemodialysis Machine</deviceName>
    <manufacturerName>AMTEC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000001277</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERACETIC AND ACETIC ACID WITH HYDROGEN PEROXIDE FOR THE DISINFECTION OF MEDICAL DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>EP001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:00:34.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580153781378</udiDi>
    <basicUdiDi>458015378SanacideSeries57</basicUdiDi>
    <tradeName>Sanacide-R7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMTEC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000001277</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERACETIC AND ACETIC ACID WITH HYDROGEN PEROXIDE FOR THE DISINFECTION OF MEDICAL DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>R7001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580153781392</udiDi>
    <basicUdiDi>458015378CitrixSeriesJG</basicUdiDi>
    <tradeName>Citrix-LA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMTEC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000001277</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>LA001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580153781477</udiDi>
    <basicUdiDi>458015378SanacideSeries57</basicUdiDi>
    <tradeName>NClean-PAA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMTEC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000001277</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PERACETIC AND ACETIC ACID WITH HYDROGEN PEROXIDE FOR THE DISINFECTION OF MEDICAL DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>PAA_001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580153781484</udiDi>
    <basicUdiDi>458015378CitrixSeriesJG</basicUdiDi>
    <tradeName>NClean-CA20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMTEC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000001277</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CA20_001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580153781491</udiDi>
    <basicUdiDi>458015378CitrixSeriesJG</basicUdiDi>
    <tradeName>NClean-CA30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMTEC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000001277</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CA30_001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.165Z</lastUpdated>
  </row>
</eudamedExport>