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<eudamedExport entity="devices">
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    <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>
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    <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>
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    <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>
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  <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>
  <row>
    <udiDi>M535SAK407A0</udiDi>
    <basicUdiDi>B-M535SAK407A0</basicUdiDi>
    <tradeName>NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK) CONCENTRATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-407-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:25.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK4070</udiDi>
    <basicUdiDi>B-M535SAK4070</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-407</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:24.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK405A0</udiDi>
    <basicUdiDi>B-M535SAK405A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-405-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:21.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK406A0</udiDi>
    <basicUdiDi>B-M535SAK406A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-406-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:20.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK4060</udiDi>
    <basicUdiDi>B-M535SAK4060</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-406</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:19.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK4050</udiDi>
    <basicUdiDi>B-M535SAK4050</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-405</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:17.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK404A0</udiDi>
    <basicUdiDi>B-M535SAK404A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-404-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:02.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK4040</udiDi>
    <basicUdiDi>B-M535SAK4040</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-404</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:01.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK403A0</udiDi>
    <basicUdiDi>B-M535SAK403A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-403-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:01.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK4030</udiDi>
    <basicUdiDi>B-M535SAK4030</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-403</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:57.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK402A0</udiDi>
    <basicUdiDi>B-M535SAK402A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-402-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:56.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK4020</udiDi>
    <basicUdiDi>B-M535SAK4020</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-402</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:55.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK401A0</udiDi>
    <basicUdiDi>B-M535SAK401A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-401-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:54.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK4010</udiDi>
    <basicUdiDi>B-M535SAK4010</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-401</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:50.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK307A0</udiDi>
    <basicUdiDi>B-M535SAK307A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-307-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:49.912Z</lastUpdated>
  </row>
</eudamedExport>