<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05903792663000</udiDi>
    <basicUdiDi>B-05903792663000</basicUdiDi>
    <tradeName>GensuPen 2</tradeName>
    <deviceName>GensuPen 2</deviceName>
    <manufacturerName>Bioton S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000030862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020299</emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEN.A4.004.16</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:05:08.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903792662997</udiDi>
    <basicUdiDi>B-05903792662997</basicUdiDi>
    <tradeName>GensuPen 2</tradeName>
    <deviceName>GensuPen 2</deviceName>
    <manufacturerName>Bioton S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000030862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020299</emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEN.A4.003.16</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:05:07.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903792662911</udiDi>
    <basicUdiDi>B-05903792662911</basicUdiDi>
    <tradeName>GensuPen 2</tradeName>
    <deviceName>GensuPen 2</deviceName>
    <manufacturerName>Bioton S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000030862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020299</emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEN.A4.002.16</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:05:03.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903792661853</udiDi>
    <basicUdiDi>B-05903792661853</basicUdiDi>
    <tradeName>GensuPen 2</tradeName>
    <deviceName>GensuPen 2</deviceName>
    <manufacturerName>Bioton S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000030862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020299</emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEN.A4.004.16</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:05:02.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903792661709</udiDi>
    <basicUdiDi>B-05903792661709</basicUdiDi>
    <tradeName>GensuPen 2</tradeName>
    <deviceName>GensuPen 2</deviceName>
    <manufacturerName>Bioton S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000030862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020299</emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEN.A4.002.16</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:05:01.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903792661693</udiDi>
    <basicUdiDi>B-05903792661693</basicUdiDi>
    <tradeName>GensuPen 2</tradeName>
    <deviceName>GensuPen 2</deviceName>
    <manufacturerName>Bioton S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000030862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A020299</emdnCode>
    <emdnDescription>REUSABLE SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEN.A4.003.16</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:05:00.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000620017</udiDi>
    <basicUdiDi>B-05430000620017</basicUdiDi>
    <tradeName>AT-Adapt</tradeName>
    <deviceName>20 mm Vented Vial Access Device</deviceName>
    <manufacturerName>Yukon Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027131</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A070199</emdnCode>
    <emdnDescription>ADAPTERS AND CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADA010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:49:16.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040815399</udiDi>
    <basicUdiDi>B-05420040815399</basicUdiDi>
    <tradeName>VMK ENDONEEDLE</tradeName>
    <deviceName>Rinsing root canal</deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010602</emdnCode>
    <emdnDescription>DENTAL IRRIGATION NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN-2825-ET</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:45:00.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277437008</udiDi>
    <basicUdiDi>0888277DC163ASTK9</basicUdiDi>
    <tradeName>00888277437008</tradeName>
    <deviceName>Suction tubing</deviceName>
    <manufacturerName>Medline International France SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000676</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0399</emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ORS78S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:49:17.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277437015</udiDi>
    <basicUdiDi>0888277DC163ASTK9</basicUdiDi>
    <tradeName>00888277437015</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medline International France SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000676</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0399</emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ORS78SF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:49:17.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277437022</udiDi>
    <basicUdiDi>0888277DC163ASTK9</basicUdiDi>
    <tradeName>00888277437022</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medline International France SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000676</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0399</emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBT78</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:49:17.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888277437039</udiDi>
    <basicUdiDi>0888277DC163ASTK9</basicUdiDi>
    <tradeName>00888277437039</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medline International France SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000676</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0399</emdnCode>
    <emdnDescription>TUBULAR DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ORS710</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:49:17.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660490</udiDi>
    <basicUdiDi>B-05391535660490</basicUdiDi>
    <tradeName>GO-ON Medical Device– Italy (Shiseido)</tradeName>
    <deviceName>GO-ON Medical Device– Italy (Shiseido)</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70968</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:30.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660438</udiDi>
    <basicUdiDi>B-05391535660438</basicUdiDi>
    <tradeName>GO-ON Medical Device– Italy (HTL)</tradeName>
    <deviceName>GO-ON Medical Device– Italy (HTL)</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70764</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:28.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660377</udiDi>
    <basicUdiDi>B-05391535660377</basicUdiDi>
    <tradeName>GO-ON Medical Device– Spanish Market (Shiseido)</tradeName>
    <deviceName>GO-ON Medical Device– Spanish Market (Shiseido)</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70705</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:27.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660353</udiDi>
    <basicUdiDi>B-05391535660353</basicUdiDi>
    <tradeName>GO-ON Medical Device– Portuguese Market (Shiseido)</tradeName>
    <deviceName>GO-ON Medical Device– Portuguese Market (Shiseido)</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70703</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:26.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660346</udiDi>
    <basicUdiDi>B-05391535660346</basicUdiDi>
    <tradeName>GO-ON Medical Device–Polish Market (Shiseido)</tradeName>
    <deviceName>GO-ON Medical Device–Polish Market (Shiseido)</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:23.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660308</udiDi>
    <basicUdiDi>B-05391535660308</basicUdiDi>
    <tradeName>GO-ON Medical Device– Baltic Markets (Estonia, Lithuania, Latvia) - Shiseido</tradeName>
    <deviceName>GO-ON Medical Device– Baltic Markets (Estonia, Lithuania, Latvia) - Shiseido</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70699</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:22.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660278</udiDi>
    <basicUdiDi>B-05391535660278</basicUdiDi>
    <tradeName>GO-ON Medical Device– Belgian Market (Shiseido)</tradeName>
    <deviceName>GO-ON Medical Device– Belgian Market (Shiseido)</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70695</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:21.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391535660261</udiDi>
    <basicUdiDi>B-05391535660261</basicUdiDi>
    <tradeName>GO-ON Medical Device- Austria (Shiseido)</tradeName>
    <deviceName>GO-ON Medical Device- Austria (Shiseido)</deviceName>
    <manufacturerName>Rottapharm Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000005490</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010799</emdnCode>
    <emdnDescription>PREFILLED SYRINGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70694</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T16:30:19.755Z</lastUpdated>
  </row>
</eudamedExport>