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<eudamedExport entity="devices">
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    <udiDi>04250203221177</udiDi>
    <basicUdiDi>42502032PRI05959</basicUdiDi>
    <tradeName>PRIMEDISILK® T-Tubus, Gr. 9, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200641</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221184</udiDi>
    <basicUdiDi>42502032PRI05959</basicUdiDi>
    <tradeName>PRIMEDISILK® T-Tubus, Gr. 10, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200642</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221191</udiDi>
    <basicUdiDi>42502032PRI05959</basicUdiDi>
    <tradeName>PRIMEDISILK® T-Tubus, Gr. 11, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200643</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221207</udiDi>
    <basicUdiDi>42502032PRI05959</basicUdiDi>
    <tradeName>PRIMEDISILK® T-Tubus, Gr. 12, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200644</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221214</udiDi>
    <basicUdiDi>42502032PRI05959</basicUdiDi>
    <tradeName>PRIMEDISILK® T-Tubus, Gr. 13, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200645</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221221</udiDi>
    <basicUdiDi>42502032PRI05959</basicUdiDi>
    <tradeName>PRIMEDISILK® T-Tubus, Gr. 14, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200646</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221511</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ III, 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>200575</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221528</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ III, 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>200571</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221535</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ III, 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>200572</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221542</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ III, 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>200573</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221696</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.8</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>201375</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203223171</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.9, L = 75 mm</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>201216</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:25.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203223676</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.13, überlang</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>200330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:11.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224321</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDICUFF®, Gr.8, L = 70 mm</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>200700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:10.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784604</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>A02A06353F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784628</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>A02A06403F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784642</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>A02A06453F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784666</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>A02A06503F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784680</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>A02A06553F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784703</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>A02A06603F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.566Z</lastUpdated>
  </row>
</eudamedExport>