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<eudamedExport entity="devices">
  <row>
    <udiDi>04250203274593</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon+ Sprechventil, signalorange mit O2-Anschluss, unsteril</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></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200261</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203274647</udiDi>
    <basicUdiDi>42502032PRI0274U</basicUdiDi>
    <tradeName>Filterkassette für NovaPhon+ Sprechventil unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200259</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203274838</udiDi>
    <basicUdiDi>42502032PRI0795F</basicUdiDi>
    <tradeName>IrriCare Basis-Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203274852</udiDi>
    <basicUdiDi>42502032PRI0795F</basicUdiDi>
    <tradeName>IrriCare Konen-Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203274876</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon+ Sprechventil, signalorange mit O2-Anschluss, 5 Stück/Faltschachtel, unsteril</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></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200261-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203274906</udiDi>
    <basicUdiDi>42502032PRI0454W</basicUdiDi>
    <tradeName>Aktiv-Passiv-Drainage, Ch.18 Drainagebeutel 500 ml mit Ablasshahn Silikondrain (800/150) mit Trokar 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></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH REDON TYPE RIGID CONTAINER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21588</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275026</udiDi>
    <basicUdiDi>42502032PRI0785D</basicUdiDi>
    <tradeName>Microguard VoiceHMEF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275095</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Kinderkatheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275101</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Luftkatheter, a 10 Stück im Beutel, unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13704</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275118</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Ballonkatheter, unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13706</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275125</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Ballonkatheter lang, unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13708</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275132</udiDi>
    <basicUdiDi>42502032PRI0014A</basicUdiDi>
    <tradeName>Luftkatheter mit Ballon, a 10 Stück im Beutel + 1 Luer-Lock Spritze pro Beutel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275163</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine Lite Gr. 10, ungefenstert mit 15 mm Konnektor</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></emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1211110-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203275194</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine Lite Gr. 10, ungefenstert, mit 15 mm Konnektor</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></emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1211110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224475</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDIPHON®, Gr.11, überlang, L = 115 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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200717</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T10:25:20.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224468</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDIPHON®, Gr.10, überlang, L = 110 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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200716</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T10:25:19.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224451</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDIPHON®, Gr.9, überlang, L = 105 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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T10:25:18.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224444</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDIPHON®, Gr.8, überlang, L = 105 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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200714</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T10:25:17.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224437</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDIPHON®, Gr.11, L = 87 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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200713</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T10:25:16.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224420</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDIPHON®, Gr.10, L = 85 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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200712</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T10:25:15.576Z</lastUpdated>
  </row>
</eudamedExport>