<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>01230000006187</udiDi>
    <basicUdiDi>B-01230000006187</basicUdiDi>
    <tradeName>01230000006187</tradeName>
    <deviceName>ECOS-300CY</deviceName>
    <manufacturerName>CytoSorbents Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002213</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-0061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:06:52.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>01230000006149</udiDi>
    <basicUdiDi>B-01230000006149</basicUdiDi>
    <tradeName>01230000006149</tradeName>
    <deviceName>PerSorb for PerLife</deviceName>
    <manufacturerName>CytoSorbents Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002213</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-0231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:06:52.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>01230000006002</udiDi>
    <basicUdiDi>B-01230000006002</basicUdiDi>
    <tradeName>CytoSorb 300</tradeName>
    <deviceName>CytoSorb 300 mL Device</deviceName>
    <manufacturerName>CytoSorbents Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002213</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-0031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:06:51.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450896000</udiDi>
    <basicUdiDi>69384508KHH2</basicUdiDi>
    <tradeName>Disposable Hemoperfusion Cartridge</tradeName>
    <deviceName>Disposable Hemoperfusion Cartridge</deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHA80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:00.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450876019</udiDi>
    <basicUdiDi>69384508BSGV</basicUdiDi>
    <tradeName>Disposable Plasma Bilirubin Adsorption Column</tradeName>
    <deviceName>Disposable Plasma Bilirubin Adsorption Column</deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:20:59.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450866003</udiDi>
    <basicUdiDi>69384508CAFU</basicUdiDi>
    <tradeName>Cytokine Adsorption Column</tradeName>
    <deviceName>Cytokine Adsorption Column</deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:20:58.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450816015</udiDi>
    <basicUdiDi>69384508HAGB</basicUdiDi>
    <tradeName>Disposable Hemoperfusion Cartridge</tradeName>
    <deviceName>Disposable Hemoperfusion Cartridge</deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HA60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:20:56.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959928790729</udiDi>
    <basicUdiDi>69599287MGMG</basicUdiDi>
    <tradeName>Disposable Hemoperfusion Cartridge</tradeName>
    <deviceName>Disposable Hemoperfusion Cartridge</deviceName>
    <manufacturerName>Foshan Biosun Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013291</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:45.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959928700360</udiDi>
    <basicUdiDi>69599287DXMP</basicUdiDi>
    <tradeName>Disposable Bilirubin Adsorption Column</tradeName>
    <deviceName>Disposable Bilirubin Adsorption Column</deviceName>
    <manufacturerName>Foshan Biosun Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013291</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX350</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:44.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959928700124</udiDi>
    <basicUdiDi>69599287DXMP</basicUdiDi>
    <tradeName>Disposable Bilirubin Adsorption Column</tradeName>
    <deviceName>Disposable Bilirubin Adsorption Column</deviceName>
    <manufacturerName>Foshan Biosun Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013291</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX250</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:38.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959928700117</udiDi>
    <basicUdiDi>69599287DXMP</basicUdiDi>
    <tradeName>Disposable Bilirubin Adsorption Column</tradeName>
    <deviceName>Disposable Bilirubin Adsorption Column</deviceName>
    <manufacturerName>Foshan Biosun Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013291</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX150</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:37.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959928700100</udiDi>
    <basicUdiDi>69599287MGMG</basicUdiDi>
    <tradeName>Disposable Hemoperfusion Cartridge</tradeName>
    <deviceName>Disposable Hemoperfusion Cartridge</deviceName>
    <manufacturerName>Foshan Biosun Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013291</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:36.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959928700094</udiDi>
    <basicUdiDi>69599287MGMG</basicUdiDi>
    <tradeName>Disposable Hemoperfusion Cartridge</tradeName>
    <deviceName>Disposable Hemoperfusion Cartridge</deviceName>
    <manufacturerName>Foshan Biosun Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013291</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T16:21:35.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450896031</udiDi>
    <basicUdiDi>69384508KHH2</basicUdiDi>
    <tradeName>06938450896031</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHA260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:51:37.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450896024</udiDi>
    <basicUdiDi>69384508KHH2</basicUdiDi>
    <tradeName>Disposable Hemoperfusion Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHA200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:51:36.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450896017</udiDi>
    <basicUdiDi>69384508KHH2</basicUdiDi>
    <tradeName>Disposable Hemoperfusion Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHA130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:51:35.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450876057</udiDi>
    <basicUdiDi>69384508BSGV</basicUdiDi>
    <tradeName>Disposable Plasma Bilirubin Adsorption</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:51:31.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450876033</udiDi>
    <basicUdiDi>69384508BSGV</basicUdiDi>
    <tradeName>Disposable Plasma Bilirubin Adsorption</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:51:30.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450873803</udiDi>
    <basicUdiDi>B-06938450873803</basicUdiDi>
    <tradeName>Disposable Plasma Bilirubin Perfusion Adsorption Column</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:51:27.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938450873308</udiDi>
    <basicUdiDi>B-06938450873308</basicUdiDi>
    <tradeName>Disposable Plasma Bilirubin Perfusion Adsorption Column</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jafron Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018067</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:51:26.754Z</lastUpdated>
  </row>
</eudamedExport>