<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944932784727</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06653F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784741</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06703F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784765</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06753F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784789</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06803F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784802</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06853F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784826</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06903F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784840</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06953F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784864</udiDi>
    <basicUdiDi>69449327FA02A02C9</basicUdiDi>
    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06963F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974909511391</udiDi>
    <basicUdiDi>697299186CA1302F7</basicUdiDi>
    <tradeName>Tracheostomy Tube</tradeName>
    <deviceName>Tracheostomy Tube</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>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:32:16.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927792</udiDi>
    <basicUdiDi>697209192RTTU35WM</basicUdiDi>
    <tradeName>BM Reinforced Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010201</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:33:00.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091921332</udiDi>
    <basicUdiDi>697209192TTTU35XF</basicUdiDi>
    <tradeName>BM Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</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>22330002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:20.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711467491312</udiDi>
    <basicUdiDi>471146749TT01E9</basicUdiDi>
    <tradeName>Rota-Trach Disposable Standard Tracheostomy Tube</tradeName>
    <deviceName>Tracheostomy tubes, without cuff</deviceName>
    <manufacturerName>Vitaltec Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000011422</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>5410700</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:10:53.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290504</udiDi>
    <basicUdiDi>426074129SilberkanuelenQC</basicUdiDi>
    <tradeName>Silber Außenkanüle</tradeName>
    <deviceName>Tracheostomakanülen aus Silber</deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</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>16570XAK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:08:49.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290467</udiDi>
    <basicUdiDi>426074129Silikonkanuele4E</basicUdiDi>
    <tradeName>silVENT Silikonkanüle</tradeName>
    <deviceName>Tracheostomakanülen aus Silikon</deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</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>2010SIL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:08:48.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290344</udiDi>
    <basicUdiDi>426074129PURKanuelen34</basicUdiDi>
    <tradeName>purVENT Außenkanüle</tradeName>
    <deviceName>Tracheostomakanülen aus PUR</deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</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>165710AK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:08:47.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949230163045</udiDi>
    <basicUdiDi>69492301QQXCG014G</basicUdiDi>
    <tradeName>Sterile Tracheostomy Tubes For Single Use</tradeName>
    <deviceName>Sterile Tracheostomy Tubes For Single Use</deviceName>
    <manufacturerName>Jiangxi Yikang Medical Instrument Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030129</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6304</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T02:04:57.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949230163038</udiDi>
    <basicUdiDi>69492301QQXCG014G</basicUdiDi>
    <tradeName>Sterile Tracheostomy Tubes For Single Use</tradeName>
    <deviceName>Sterile Tracheostomy Tubes For Single Use</deviceName>
    <manufacturerName>Jiangxi Yikang Medical Instrument Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030129</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6303</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T02:04:54.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949230163021</udiDi>
    <basicUdiDi>69492301QQXCG014G</basicUdiDi>
    <tradeName>Sterile Tracheostomy Tubes For Single Use</tradeName>
    <deviceName>Sterile Tracheostomy Tubes For Single Use</deviceName>
    <manufacturerName>Jiangxi Yikang Medical Instrument Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030129</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T02:04:51.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949230163014</udiDi>
    <basicUdiDi>69492301QQXCG014G</basicUdiDi>
    <tradeName>Sterile Tracheostomy Tubes For Single Use</tradeName>
    <deviceName>Sterile Tracheostomy Tubes For Single Use</deviceName>
    <manufacturerName>Jiangxi Yikang Medical Instrument Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030129</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6301</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T02:04:48.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949230163007</udiDi>
    <basicUdiDi>69492301QQXCG014G</basicUdiDi>
    <tradeName>Sterile Tracheostomy Tubes For Single Use</tradeName>
    <deviceName>Sterile Tracheostomy Tubes For Single Use</deviceName>
    <manufacturerName>Jiangxi Yikang Medical Instrument Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030129</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T02:04:47.410Z</lastUpdated>
  </row>
</eudamedExport>