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    <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>
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  <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06853F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.424Z</lastUpdated>
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  <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06903F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.392Z</lastUpdated>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>04250203224598</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, kurz, Gr. 8 kurz/ short ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224604</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, Gr. 8  ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224611</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, kurz, Gr. 9 kurz/ short ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200556</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224628</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, Gr. 9  ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200551</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224635</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, kurz, Gr. 10 kurz/ short ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200557</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224642</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, Gr. 10  ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200552</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224659</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, kurz, Gr. 11 kurz/ short ohne Ösen/ withaut eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200558</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.269Z</lastUpdated>
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  <row>
    <udiDi>04250203224666</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, Gr. 11  ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200553</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224673</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, kurz, Gr. 12 kurz/ short ohne Ösen/ without eyelets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>200559</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:22.214Z</lastUpdated>
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