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    <tradeName>PercuTrach® PDT-Set Typ 2 + Optima Suction, Gr.9 steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112356</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:37.734Z</lastUpdated>
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    <udiDi>04250203220576</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Basic Cuff, Gr.7 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:37.709Z</lastUpdated>
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    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Basic Cuff, Gr.8 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:37.687Z</lastUpdated>
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    <udiDi>04250203220590</udiDi>
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    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Basic Cuff, Gr.9 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112426</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:37.664Z</lastUpdated>
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    <udiDi>04250203220606</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Suction, Gr.7 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112454</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:37.636Z</lastUpdated>
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  <row>
    <udiDi>04250203220613</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Suction, Gr.8 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112455</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:37.613Z</lastUpdated>
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    <udiDi>04250203220620</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Suction, Gr.9 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>112456</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:37.586Z</lastUpdated>
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    <udiDi>04250203221733</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Voice Cuff, Gr.8 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112435</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.564Z</lastUpdated>
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  <row>
    <udiDi>04250203221740</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Suction Voice, Gr.8 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112445</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.535Z</lastUpdated>
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  <row>
    <udiDi>04250203221801</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Voice Cuff, Gr.7 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112434</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182628499</udiDi>
    <basicUdiDi>B-04711182628499</basicUdiDi>
    <tradeName>Slllcone Tracheostomy Tube, Ordinary Cuff</tradeName>
    <deviceName>Slllcone Tracheostomy Tube, Ordinary Cuff</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1560-0085</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:59:52.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784369</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05351F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784383</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05401F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.956Z</lastUpdated>
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  <row>
    <udiDi>06944932784406</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05451F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.936Z</lastUpdated>
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  <row>
    <udiDi>06944932784420</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05501F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784444</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05551F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784468</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05601F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784482</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05651F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784505</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05701F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932784512</udiDi>
    <basicUdiDi>69449327FA02A01C7</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A05751F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:25.804Z</lastUpdated>
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