<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03661379279212</udiDi>
    <basicUdiDi>3661379ASS15PER2ANY</basicUdiDi>
    <tradeName>SET BR/DBR VVC</tradeName>
    <deviceName>Assemblage PERFUSION STE</deviceName>
    <manufacturerName>HEMODIA SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000007189</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8384_B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:51:53.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00886874125700</udiDi>
    <basicUdiDi>08868741202177H</basicUdiDi>
    <tradeName>CO2 Tank Gas Accessory</tradeName>
    <deviceName>CO2 Tank Gas Accessory</deviceName>
    <manufacturerName>Intuitive Surgical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020711</manufacturerSrn>
    <authorisedRepresentativeName>Intuitive Surgical SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009053</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>380743</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:29:41.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022888014</udiDi>
    <basicUdiDi>0850228881000112504W</basicUdiDi>
    <tradeName>SmartDose</tradeName>
    <deviceName>SmartDose On-Body Delivery System (1.2mL)</deviceName>
    <manufacturerName>West Pharmaceutical Services AZ, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020637</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100012369</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:28:58.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022888007</udiDi>
    <basicUdiDi>08502288810001132452</basicUdiDi>
    <tradeName>SmartDose</tradeName>
    <deviceName>SmartDose On-Body Delivery System (2.4mL)</deviceName>
    <manufacturerName>West Pharmaceutical Services AZ, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020637</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100012423</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:28:56.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688499</udiDi>
    <basicUdiDi>0850025688FlowEaseB7</basicUdiDi>
    <tradeName>FlowEase [Subcutaneous] Infusion Set, 6mm</tradeName>
    <deviceName>FlowEase</deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014749</manufacturerSrn>
    <authorisedRepresentativeName>Takeda Pharmaceuticals International AG Ireland Branch</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU1M3006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:12.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688277</udiDi>
    <basicUdiDi>0850025688Veyvondi_PackFK</basicUdiDi>
    <tradeName>Administration pack for Veyvondi</tradeName>
    <deviceName>Administration Pack for Veyvondi</deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000007896</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5500359</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:05.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688208</udiDi>
    <basicUdiDi>0850025688Firazyr_PackK9</basicUdiDi>
    <tradeName>00850025688208</tradeName>
    <deviceName>Firazyr® Pediatric Administration Kit</deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000007896</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000568</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:03.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025688055</udiDi>
    <basicUdiDi>0850025688Lessines_PackSE</basicUdiDi>
    <tradeName>Administration Kit Advate, BAXJECT II, 2ml</tradeName>
    <deviceName>Administration Kits for Advate, Adynovi and Rixubis</deviceName>
    <manufacturerName>Takeda Pharmaceuticals U.S.A., Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000007896</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3400721</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:01.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>00801741066160</udiDi>
    <basicUdiDi>0801741EPBTARBBRG</basicUdiDi>
    <tradeName>SafeStep</tradeName>
    <deviceName>SafeStep™ Huber Needle Set</deviceName>
    <manufacturerName>Bard Access Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017720</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH-0029</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:20:42.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00801741048289</udiDi>
    <basicUdiDi>0801741JOBXOCKQXS</basicUdiDi>
    <tradeName>POWERLOC</tradeName>
    <deviceName>PowerLoc™ Safety Infusion Set</deviceName>
    <manufacturerName>Bard Access Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017720</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8651910</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:20:42.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>00801741047503</udiDi>
    <basicUdiDi>0801741NPERWKIL4F</basicUdiDi>
    <tradeName>MINILOC</tradeName>
    <deviceName>MiniLoc™ Safety Infusion Set</deviceName>
    <manufacturerName>Bard Access Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017720</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0631910</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:20:41.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00801741047329</udiDi>
    <basicUdiDi>0801741WBBHHNCKS6</basicUdiDi>
    <tradeName>POWERLOC</tradeName>
    <deviceName>PowerLoc™ Max Power Injectable Infusion Set</deviceName>
    <manufacturerName>Bard Access Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017720</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0131910</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:20:36.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>00616258010557</udiDi>
    <basicUdiDi>0616258TFCN-0073QH</basicUdiDi>
    <tradeName>MEDRAD® Intego</tradeName>
    <deviceName>MEDRAD® Intego Disposables</deviceName>
    <manufacturerName>Bayer Medical Care Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007050</manufacturerSrn>
    <authorisedRepresentativeName>Bayer Medical Care B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000240</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT CPS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:04:46.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905608</udiDi>
    <basicUdiDi>037005129INF-ESTT</basicUdiDi>
    <tradeName>03700512905608</tradeName>
    <deviceName>Infusion Lines</deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM000010B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:15:49.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905103</udiDi>
    <basicUdiDi>037005129GSU-IAX9</basicUdiDi>
    <tradeName>03700512905103</tradeName>
    <deviceName>Irrigation and/or aspiration lines</deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:15:48.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729752981</udiDi>
    <basicUdiDi>01915060000000000000586NV</basicUdiDi>
    <tradeName>SAPS™</tradeName>
    <deviceName>Single Action Pumping System</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0067201000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:09:09.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976143667209</udiDi>
    <basicUdiDi>697614366JL00LA</basicUdiDi>
    <tradeName>Universal Irrigation Set -1or2 Ways</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Juneland Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034149</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L15315</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:01:18.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906065481742</udiDi>
    <basicUdiDi>890606548I04LY</basicUdiDi>
    <tradeName>Maisfusion Set™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mais India Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000021842</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI/CA/01-000-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:11.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>00085412718095</udiDi>
    <basicUdiDi>0085412GMDN000000000062WU</basicUdiDi>
    <tradeName>DISPOSABLE CURVED APPLICATOR</tradeName>
    <deviceName>DISPOSABLE CURVED APPLICATOR</deviceName>
    <manufacturerName>Baxter Healthcare SA</manufacturerName>
    <manufacturerSrn>CH-MF-000026124</manufacturerSrn>
    <authorisedRepresentativeName>Baxter Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A030499</emdnCode>
    <emdnDescription>ADMINISTRATION KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADS201894</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:32:43.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>00085412653518</udiDi>
    <basicUdiDi>00854120000000000000118JA</basicUdiDi>
    <tradeName>PCEA Syringe Sets</tradeName>
    <deviceName>PCEA Syringe Set</deviceName>
    <manufacturerName>Baxter Healthcare SA</manufacturerName>
    <manufacturerSrn>CH-MF-000026124</manufacturerSrn>
    <authorisedRepresentativeName>Baxter Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2P3334</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:32:41.485Z</lastUpdated>
  </row>
</eudamedExport>