<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08906183411218</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183411218</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-CT-402-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:35:00.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412031</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183412031</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-CT-402-3.78</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:35:00.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183413090</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183413090</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-CT-402-0.840</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:34:59.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411270</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183411270</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-CT-403-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:34:59.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411300</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183411300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-CT-403-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:34:59.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412062</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183412062</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-CT-403-3.78</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:34:59.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183413083</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183413083</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-CT-403-0.840</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:34:59.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183410020</udiDi>
    <basicUdiDi>890618341SLHCALBPAF</basicUdiDi>
    <tradeName>08906183410020</tradeName>
    <deviceName>Concentrated Haemodialysis Solution</deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-R-101-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:57:04.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183410006</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 45X DEXTROSE</tradeName>
    <deviceName>Dry Haemodialysis Concentrate</deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-301-32.03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:57:02.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001270506</udiDi>
    <basicUdiDi>B-05310001270506</basicUdiDi>
    <tradeName>AMINAL CITRATE CD-1,50 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>1010278</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:53:01.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001270384</udiDi>
    <basicUdiDi>B-05310001270384</basicUdiDi>
    <tradeName>AMINAL CITRATE CD 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>1010266</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:53:01.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001246280</udiDi>
    <basicUdiDi>B-05310001246280</basicUdiDi>
    <tradeName>AMINAL-BCD 0,50/1 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>1008198</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:52:59.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>05310001250119</udiDi>
    <basicUdiDi>B-05310001250119</basicUdiDi>
    <tradeName>AMINAL-BC 0,50 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>1008570</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:52:57.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411225</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-101-2.336</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:26.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411409</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-101-22.09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:26.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412994</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-101-0.895</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:18.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183413007</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-101-8.47</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:18.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183410754</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-R-102-9.885</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:17.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411232</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-R-102-1.977</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:16.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183413014</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-R-102-0.895</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:15.315Z</lastUpdated>
  </row>
</eudamedExport>