<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04026704388790</udiDi>
    <basicUdiDi>B-04026704388790</basicUdiDi>
    <tradeName>SMOOTH-FLO FLEX WITH DOUBLE SWIVEL</tradeName>
    <deviceName>CATHETER MOUNT</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:43:06.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704388783</udiDi>
    <basicUdiDi>B-04026704388783</basicUdiDi>
    <tradeName>SMOOTH FLO FLEX WITH  DOUBLE SWIVEL STERILE</tradeName>
    <deviceName>CATHETER MOUNT</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:43:05.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704388776</udiDi>
    <basicUdiDi>B-04026704388776</basicUdiDi>
    <tradeName>EXPANDI-FLEX</tradeName>
    <deviceName>EXPANDI-FLEX TUBE</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22362</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:43:01.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704388769</udiDi>
    <basicUdiDi>B-04026704388769</basicUdiDi>
    <tradeName>FLEXTUBE STERILE</tradeName>
    <deviceName>HUMID-VENT FLEX TUBE</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:43:00.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704572908</udiDi>
    <basicUdiDi>B-04026704572908</basicUdiDi>
    <tradeName>FIX CATHETER MOUNT WITH ELBOW 40CM , 15M-22M/15F, STERILE</tradeName>
    <deviceName>CATHETER MOUNT</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191009-000400</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:39:06.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512925910</udiDi>
    <basicUdiDi>037005129ACC02MS</basicUdiDi>
    <tradeName>03700512925910</tradeName>
    <deviceName></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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020302</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WAC202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:13.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102707</udiDi>
    <basicUdiDi>69239801ND2DBNR</basicUdiDi>
    <tradeName>nCannula Kit, #4&amp;5</tradeName>
    <deviceName>Disposable Bubble CPAP system</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0064</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-07-21T15:28:36.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980103971</udiDi>
    <basicUdiDi>69239801ND2DBNR</basicUdiDi>
    <tradeName>nCannula Kit, #6&amp;7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0065</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T15:27:56.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704561070</udiDi>
    <basicUdiDi>B-04026704561070</basicUdiDi>
    <tradeName>FIX CATHETER MOUNT WITH ELBOW 15CM , 15M-22M/15F, STERILE</tradeName>
    <deviceName>CATHETER MOUNT</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191009-000150</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:58:34.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900386</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27B11</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:45.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901550</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27A01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:42.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901567</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27B01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:42.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901574</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27C11</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:42.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901581</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27C01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:42.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901598</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27D11</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:42.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901604</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27E11</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-20T12:17:42.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290017096773</udiDi>
    <basicUdiDi>7290017096VentwayPCZ8</basicUdiDi>
    <tradeName>Patient Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-550F</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:55:13.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290017096763</udiDi>
    <basicUdiDi>7290017096VentwayPCZ8</basicUdiDi>
    <tradeName>Patient Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-1450F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:39.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290017096909</udiDi>
    <basicUdiDi>7290017096VentwayPCZ8</basicUdiDi>
    <tradeName>Patient Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-1390</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:39.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290017096902</udiDi>
    <basicUdiDi>7290017096VentwayPCZ8</basicUdiDi>
    <tradeName>Patient Circuit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inovytec Medical Solutions Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034055</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VWSP-390</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T19:45:39.707Z</lastUpdated>
  </row>
</eudamedExport>