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<eudamedExport entity="devices">
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    <basicUdiDi>42502032PRI0624W</basicUdiDi>
    <tradeName>Trachealkanüle Ultrasoft Basic Gr.7</tradeName>
    <deviceName>Optima, Ultrasoft, ProLine</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:52:26.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203220729</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.10, überlang, L = 115 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201228</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:52:25.173Z</lastUpdated>
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  <row>
    <udiDi>04250203214476</udiDi>
    <basicUdiDi>42502032PRI06656</basicUdiDi>
    <tradeName>Kinderkanüle PEDL 6,0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200067</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:52:10.864Z</lastUpdated>
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  <row>
    <udiDi>14250105600008</udiDi>
    <basicUdiDi>42501056-2.1.1-V4</basicUdiDi>
    <tradeName>Tracheostomy Necktape Length: 475 mm</tradeName>
    <deviceName>Tube Fixations - Tracheostomy Necktape blue</deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40-0005-033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:48:53.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701556401408</udiDi>
    <basicUdiDi>37015564RESPIRATOIREAL</basicUdiDi>
    <tradeName>SET POST OP 3 SOINS 1</tradeName>
    <deviceName>RESPIRATOIRE</deviceName>
    <manufacturerName>INNOSET</manufacturerName>
    <manufacturerSrn>FR-PR-000001655</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010599</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T9921</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:03:28.054Z</lastUpdated>
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  <row>
    <udiDi>14026704739018</udiDi>
    <basicUdiDi>08019020000000000000183KT</basicUdiDi>
    <tradeName>EXTRA TRACFLEX PLUS TRACHEOSTOMY SIZE 7</tradeName>
    <deviceName>RÜSCH Extra Tracflex (cuff only)</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105020202</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120214-000070</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:34:17.708Z</lastUpdated>
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  <row>
    <udiDi>15019517382846</udiDi>
    <basicUdiDi>0610586M0158DG</basicUdiDi>
    <tradeName>15019517382846</tradeName>
    <deviceName>Disconnect Wedge 15mm NS + 25/BX</deviceName>
    <manufacturerName>ICU Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009764</manufacturerSrn>
    <authorisedRepresentativeName>ICU Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002748</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011-DWG300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:00:38.323Z</lastUpdated>
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  <row>
    <udiDi>15019517382570</udiDi>
    <basicUdiDi>0610586M0055D5</basicUdiDi>
    <tradeName>15019517382570</tradeName>
    <deviceName>Bivona Inner Cannula Cleaning Swab, N/S 30/BX</deviceName>
    <manufacturerName>ICU Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009764</manufacturerSrn>
    <authorisedRepresentativeName>ICU Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002748</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011-BICSWB</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:00:36.717Z</lastUpdated>
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  <row>
    <udiDi>15019517382563</udiDi>
    <basicUdiDi>0610586M0301CV</basicUdiDi>
    <tradeName>15019517382563</tradeName>
    <deviceName>Inner Cannula Cleaning Swab for UniPerc Adjustable Flange Tracheostomy Tube, 5/EA</deviceName>
    <manufacturerName>ICU Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009764</manufacturerSrn>
    <authorisedRepresentativeName>ICU Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002748</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011-100/855/000CZ</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:00:34.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>15019517382488</udiDi>
    <basicUdiDi>0610586M0335DE</basicUdiDi>
    <tradeName>15019517382488</tradeName>
    <deviceName>Tracheostomy Tube Holder, Adult 1/EA</deviceName>
    <manufacturerName>ICU Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009764</manufacturerSrn>
    <authorisedRepresentativeName>ICU Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002748</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011-520000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:00:32.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>15019517382525</udiDi>
    <basicUdiDi>0610586M0336DG</basicUdiDi>
    <tradeName>15019517382525</tradeName>
    <deviceName>Tracheostomy Strap NS + 1/EA</deviceName>
    <manufacturerName>ICU Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009764</manufacturerSrn>
    <authorisedRepresentativeName>ICU Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002748</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011-69-0600TS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:00:30.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>111823019558</udiDi>
    <basicUdiDi>PP12633TRACHEOSTOMYTUB29</basicUdiDi>
    <tradeName>111823019558</tradeName>
    <deviceName>Tracheostomy Tube</deviceName>
    <manufacturerName>Qureshi Manufacturing Corporation</manufacturerName>
    <manufacturerSrn>PK-MF-000024744</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Tracheostomy Tube</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:43:22.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ETT9014EK3</udiDi>
    <basicUdiDi>B-ETT9014EK3</basicUdiDi>
    <tradeName>Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETT9014E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:07:54.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ETT8514EKT</udiDi>
    <basicUdiDi>B-ETT8514EKT</basicUdiDi>
    <tradeName>Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETT8514E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:07:40.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ETT8014EJQ</udiDi>
    <basicUdiDi>B-ETT8014EJQ</basicUdiDi>
    <tradeName>Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETT8014E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:07:24.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ETT7514EKG</udiDi>
    <basicUdiDi>B-ETT7514EKG</basicUdiDi>
    <tradeName>Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETT7514E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:07:06.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ETT7014EJD</udiDi>
    <basicUdiDi>B-ETT7014EJD</basicUdiDi>
    <tradeName>Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETT7014E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:06:39.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ETT6514EK5</udiDi>
    <basicUdiDi>B-ETT6514EK5</basicUdiDi>
    <tradeName>Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETT6514E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:06:14.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ETT6014EJ2</udiDi>
    <basicUdiDi>B-ETT6014EJ2</basicUdiDi>
    <tradeName>Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETT6014E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:05:41.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>89042427011570</udiDi>
    <basicUdiDi>B-89042427011570</basicUdiDi>
    <tradeName>89042427011570</tradeName>
    <deviceName>Tracheostomy Tube Cuffed</deviceName>
    <manufacturerName>Sterimed Group</manufacturerName>
    <manufacturerSrn>IN-MF-000032688</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMD 702C</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:28.962Z</lastUpdated>
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