<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>25420045505275</udiDi>
    <basicUdiDi>54200455GSSFLUENTMULTIH7</basicUdiDi>
    <tradeName>Fluent Fluid Management System Tissue Trap</tradeName>
    <deviceName>Fluent Fluid Management System Waste Bag; Fluent Fluid Management System Tissue Trap; Fluent Pro Fluid Management System Waste Bag; Fluent Pro Fluid Management System Tissue Trap</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A080299</emdnCode>
    <emdnDescription>INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLT-010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:47.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045516144</udiDi>
    <basicUdiDi>54200455GSSFLUENTDISPZN</basicUdiDi>
    <tradeName>Fluent Pro Fluid Management System Procedure Kit</tradeName>
    <deviceName>Fluent Pro Fluid Management System Disposable Procedure Kit</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLT-212S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:36.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260537490125</udiDi>
    <basicUdiDi>42605374914300MR</basicUdiDi>
    <tradeName>PEGA® BAG 300 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Venner Medical (Deutschland) GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005934</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:45:57.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260537490095</udiDi>
    <basicUdiDi>42605374914050MR</basicUdiDi>
    <tradeName>PEGA® BAG 50 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Venner Medical (Deutschland) GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005934</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:45:57.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260537490118</udiDi>
    <basicUdiDi>42605374914150MW</basicUdiDi>
    <tradeName>PEGA® BAG 150 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Venner Medical (Deutschland) GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005934</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:45:54.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260537490101</udiDi>
    <basicUdiDi>42605374914100MF</basicUdiDi>
    <tradeName>PEGA® BAG 100 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Venner Medical (Deutschland) GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005934</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:45:54.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938820548706</udiDi>
    <basicUdiDi>B-06938820548706</basicUdiDi>
    <tradeName>06938820548706</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SCW Medicath Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019140</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080299</emdnCode>
    <emdnDescription>INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41.05.20001 41.05.20002 41.05.20003 41.05.30001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:10:28.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426440</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:33.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426433</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:31.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426426</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:29.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426419</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:28.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426402</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:27.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426396</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:25.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426389</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:23.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426372</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:22.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426365</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:21.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426358</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:19.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426341</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:18.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426334</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:16.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937036426327</udiDi>
    <basicUdiDi>697299186CM41C01PC</basicUdiDi>
    <tradeName>Medication Cassette Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:15.077Z</lastUpdated>
  </row>
</eudamedExport>