<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>05310001271480</udiDi>
    <basicUdiDi>B-05310001271480</basicUdiDi>
    <tradeName>AMINAL CITRATE BCD/3 5 L</tradeName>
    <deviceName>Concentrate for Haemodialysis</deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010324</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:29:36.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001227999</udiDi>
    <basicUdiDi>B-05310001227999</basicUdiDi>
    <tradeName>AMINAL-BC 0,50-1,50 10 L</tradeName>
    <deviceName>Concentrate for Haemodialysis</deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006618</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:29:32.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001216177</udiDi>
    <basicUdiDi>B-05310001216177</basicUdiDi>
    <tradeName>AMINAL-BCD/3-1,50 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005542</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001216184</udiDi>
    <basicUdiDi>B-05310001216184</basicUdiDi>
    <tradeName>AMINAL-BCD/3 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005543</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001217563</udiDi>
    <basicUdiDi>B-05310001217563</basicUdiDi>
    <tradeName>AMINAL-BC/3-1,50 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005656</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001217587</udiDi>
    <basicUdiDi>B-05310001217587</basicUdiDi>
    <tradeName>AMINAL BC/3 -1,25 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005658</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001217624</udiDi>
    <basicUdiDi>B-05310001217624</basicUdiDi>
    <tradeName>AMINAL-BCD/3-1,25 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005662</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001220372</udiDi>
    <basicUdiDi>B-05310001220372</basicUdiDi>
    <tradeName>AMINAL-14 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005950</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001220464</udiDi>
    <basicUdiDi>B-05310001220464</basicUdiDi>
    <tradeName>AMINAL-CD-1,25 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005609</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221102</udiDi>
    <basicUdiDi>B-05310001221102</basicUdiDi>
    <tradeName>AMINAL-CD 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006048</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221119</udiDi>
    <basicUdiDi>B-05310001221119</basicUdiDi>
    <tradeName>AMINAL-CD/3 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006049</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221126</udiDi>
    <basicUdiDi>B-05310001221126</basicUdiDi>
    <tradeName>AMINAL-CD/3-1,25 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006050</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221133</udiDi>
    <basicUdiDi>B-05310001221133</basicUdiDi>
    <tradeName>AMINAL-CD/3-1,50 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006051</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221140</udiDi>
    <basicUdiDi>B-05310001221140</basicUdiDi>
    <tradeName>AMINAL-CD-1,50 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006052</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221522</udiDi>
    <basicUdiDi>B-05310001221522</basicUdiDi>
    <tradeName>AMINAL-CD 0,50/3-1,50 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006100</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221539</udiDi>
    <basicUdiDi>B-05310001221539</basicUdiDi>
    <tradeName>AMINAL-CD 0,50-1,25 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006101</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001221546</udiDi>
    <basicUdiDi>B-05310001221546</basicUdiDi>
    <tradeName>AMINAL-CD 0,50-1,50 10 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006102</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T21:23:42.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001271558</udiDi>
    <basicUdiDi>B-05310001271558</basicUdiDi>
    <tradeName>AMINAL CITRATE BC 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010313</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:24:17.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001271527</udiDi>
    <basicUdiDi>B-05310001271527</basicUdiDi>
    <tradeName>AMINAL CITRATE BC/3 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010310</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:24:15.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001260644</udiDi>
    <basicUdiDi>B-05310001260644</basicUdiDi>
    <tradeName>AMINAL CITRATE BCD/3-1,50 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1008945</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:24:02.306Z</lastUpdated>
  </row>
</eudamedExport>