<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08886483506022</udiDi>
    <basicUdiDi>B-08886483506022</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020202</emdnCode>
    <emdnDescription>CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000017-42</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:31.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506015</udiDi>
    <basicUdiDi>B-08886483506015</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020202</emdnCode>
    <emdnDescription>CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000017-27</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:30.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505995</udiDi>
    <basicUdiDi>B-08886483505995</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000015-66</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:29.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505988</udiDi>
    <basicUdiDi>B-08886483505988</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000015-57</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:29.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505964</udiDi>
    <basicUdiDi>B-08886483505964</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catheterization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catheterization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000015-55</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:25.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505957</udiDi>
    <basicUdiDi>B-08886483505957</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000015-44</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:24.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505940</udiDi>
    <basicUdiDi>B-08886483505940</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000015-43</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:11.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505933</udiDi>
    <basicUdiDi>B-08886483505933</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catheterization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020203</emdnCode>
    <emdnDescription>CENTRAL VENOUS MULTI-LUMEN (&gt;2) CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000015-30</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:08.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505889</udiDi>
    <basicUdiDi>B-08886483505889</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catheterization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catheterization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-66</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:07.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505872</udiDi>
    <basicUdiDi>B-08886483505872</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-61</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:06.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505865</udiDi>
    <basicUdiDi>B-08886483505865</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-60</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:04.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505810</udiDi>
    <basicUdiDi>B-08886483505810</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-55</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:02.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505803</udiDi>
    <basicUdiDi>B-08886483505803</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-54</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:00.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505797</udiDi>
    <basicUdiDi>B-08886483505797</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-48</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:41:00.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505780</udiDi>
    <basicUdiDi>B-08886483505780</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-47</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:58.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505773</udiDi>
    <basicUdiDi>B-08886483505773</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-46</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:56.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505766</udiDi>
    <basicUdiDi>B-08886483505766</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-45</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:54.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505759</udiDi>
    <basicUdiDi>B-08886483505759</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-37</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:53.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505711</udiDi>
    <basicUdiDi>B-08886483505711</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000011-05</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:52.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505674</udiDi>
    <basicUdiDi>B-08886483505674</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catherization Kit</tradeName>
    <deviceName>Central Venous Catheter and Catherization Kit</deviceName>
    <manufacturerName>Bioptimal International PTE. LTD.</manufacturerName>
    <manufacturerSrn>SG-MF-000010306</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01020201</emdnCode>
    <emdnDescription>CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000009-54</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:49.603Z</lastUpdated>
  </row>
</eudamedExport>