<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08886483506343</udiDi>
    <basicUdiDi>B-08886483506343</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>25-000021-56</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:25.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506336</udiDi>
    <basicUdiDi>B-08886483506336</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>25-000021-55</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:21.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506329</udiDi>
    <basicUdiDi>B-08886483506329</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>25-000021-38</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:19.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506312</udiDi>
    <basicUdiDi>B-08886483506312</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>25-000021-37</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:18.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506275</udiDi>
    <basicUdiDi>B-08886483506275</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>25-000021-12</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:15.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506206</udiDi>
    <basicUdiDi>B-08886483506206</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>25-000019-51</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:12.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506190</udiDi>
    <basicUdiDi>B-08886483506190</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>25-000019-50</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:09.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506183</udiDi>
    <basicUdiDi>B-08886483506183</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>25-000019-49</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:07.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506176</udiDi>
    <basicUdiDi>B-08886483506176</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>25-000019-42</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:02.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506169</udiDi>
    <basicUdiDi>B-08886483506169</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>25-000019-21</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:01.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506107</udiDi>
    <basicUdiDi>B-08886483506107</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>25-000017-64</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:29:00.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506091</udiDi>
    <basicUdiDi>B-08886483506091</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>25-000017-63</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:28:58.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506084</udiDi>
    <basicUdiDi>B-08886483506084</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>C01020202</emdnCode>
    <emdnDescription>CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-000017-62</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:28:51.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506077</udiDi>
    <basicUdiDi>B-08886483506077</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>25-000017-61</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:28:50.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506060</udiDi>
    <basicUdiDi>B-08886483506060</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>25-000017-60</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:28:49.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506053</udiDi>
    <basicUdiDi>B-08886483506053</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>25-000017-59</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:28:48.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506046</udiDi>
    <basicUdiDi>B-08886483506046</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>25-000017-52</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:28:42.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483506039</udiDi>
    <basicUdiDi>B-08886483506039</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>25-000017-51</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:28:40.841Z</lastUpdated>
  </row>
  <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>2026-07-01T04:28:39.662Z</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>2026-07-01T04:28:38.427Z</lastUpdated>
  </row>
</eudamedExport>