<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08886483505667</udiDi>
    <basicUdiDi>B-08886483505667</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>25-000009-45</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:48.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505629</udiDi>
    <basicUdiDi>B-08886483505629</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>25-000007-21</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:47.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505612</udiDi>
    <basicUdiDi>B-08886483505612</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>25-000007-17</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:45.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505605</udiDi>
    <basicUdiDi>B-08886483505605</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>25-000004-99</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:43.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505599</udiDi>
    <basicUdiDi>B-08886483505599</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>25-000004-97</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:41.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505575</udiDi>
    <basicUdiDi>B-08886483505575</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>25-000004-94</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:40.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505568</udiDi>
    <basicUdiDi>B-08886483505568</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>25-000004-90</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:39.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505551</udiDi>
    <basicUdiDi>B-08886483505551</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>25-000004-89</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:36.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505544</udiDi>
    <basicUdiDi>B-08886483505544</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>25-000004-88</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:35.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505537</udiDi>
    <basicUdiDi>B-08886483505537</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>25-000004-87</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:34.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505520</udiDi>
    <basicUdiDi>B-08886483505520</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>25-000004-86</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:32.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505513</udiDi>
    <basicUdiDi>B-08886483505513</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>25-000004-78</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:30.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505506</udiDi>
    <basicUdiDi>B-08886483505506</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>25-000004-63</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:28.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505490</udiDi>
    <basicUdiDi>B-08886483505490</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>25-000004-62</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:27.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505414</udiDi>
    <basicUdiDi>B-08886483505414</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>25-000001-99</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:26.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505407</udiDi>
    <basicUdiDi>B-08886483505407</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>25-000001-98</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:23.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505391</udiDi>
    <basicUdiDi>B-08886483505391</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>25-000001-97</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:11.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505384</udiDi>
    <basicUdiDi>B-08886483505384</basicUdiDi>
    <tradeName>Bioptimal Central Venous Catheter and Catheterization 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>25-000001-85</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:10.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505377</udiDi>
    <basicUdiDi>B-08886483505377</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>25-000001-70</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:08.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>08886483505360</udiDi>
    <basicUdiDi>B-08886483505360</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>25-000001-69</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:40:06.313Z</lastUpdated>
  </row>
</eudamedExport>