<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08906183412352</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 2.0 Mmols/liter Potassium 35X, 19.73gm</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-SPK-220-19.73</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:46:21.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412321</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.0 Mmols/liter Potassium 35X, 9.87gm</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-SPK-219-9.87</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:46:21.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412345</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.0 Mmols/liter Potassium 35X, 26.1gm</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-SPK-219-26.1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:46:20.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412338</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.0 Mmols/liter Potassium 35X, 13.05gm</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-SPK-219-13.05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:46:20.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412253</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 0.25 Mmols/liter Calcium 36.83X, 13.5gm</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-SPC-117-13.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:46:20.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412246</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 0.25 Mmols/liter Calcium 36.83X, 6.75gm</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-SPC-117-6.75</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:46:20.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412239</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 0.25 Mmols/liter Calcium 36.83X, 5.11gm</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-SPC-117-5.11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:46:00.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412222</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.8 Mmols/liter Potassium 36.83X, 49.5gm</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-SPK-116-49.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:07.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412215</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.8 Mmols/liter Potassium 36.83X, 24.75gm</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-SPK-116-24.75</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:07.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412284</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.0 Mmols/liter Potassium 36.83X, 27.5gm</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-SPK-115-27.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:07.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412277</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.0 Mmols/liter Potassium 36.83X, 13.75gm</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-SPK-115-13.75</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:06.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412260</udiDi>
    <basicUdiDi>890618341SLHC00BPKE7</basicUdiDi>
    <tradeName>Spike 1.0 Mmols/liter Potassium 36.83X, 10.40gm</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-SPK-115-10.40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:06.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411942</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>HAEMODIALYSIS BICARBONATE BAG</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-HBB-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:03.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411959</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>HAEMODIALYSIS BICARBONATE BAG</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-HBB-555</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:03.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411966</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>HAEMODIALYSIS BICARBONATE BAG</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-HBB-650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:03.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411980</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>HAEMODIALYSIS BICARBONATE BAG</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-HBB-720</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:03.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411997</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>HAEMODIALYSIS BICARBONATE BAG</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-HBB-760</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:03.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183412000</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>HAEMODIALYSIS BICARBONATE BAG</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-HBB-900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:03.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411874</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>SL-Bag</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-SB-555</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:02.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906183411843</udiDi>
    <basicUdiDi>890618341SLHC00BPBDM</basicUdiDi>
    <tradeName>SL-Bag</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>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-SB-650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:45:02.909Z</lastUpdated>
  </row>
</eudamedExport>