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<eudamedExport entity="devices">
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    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon Sprechventil, weiß 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>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:01.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203273633</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon Sprechventil, magenta 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>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:01.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203273657</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon Sprechventil, lemon 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>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200242</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:01.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203273671</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon Sprechventil, signal orange 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>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:01.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203273695</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon Sprechventil, hautfarben 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>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:01.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203274456</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon Sprechventil, signal orange mit O2-Anschluss, 10 Stück/Faltschachtel</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>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200243-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:01.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203274579</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>NovaPhon+ Sprechventil, hautfarben 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>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.957Z</lastUpdated>
  </row>
  <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>R90060202</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>R90060202</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>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>R90060202</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>05060413640618</udiDi>
    <basicUdiDi>506041364TF013W3</basicUdiDi>
    <tradeName>Tracheostomy Speaking Valve (Blue)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSV/150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:40.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290153</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Sprechventil für purVENT**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19509</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:26.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290146</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Sprechventil eckig für Silber Innenkanüle mit Filtertasche**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:25.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290139</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Sprechventil rund für Silber Innenkanüle mit Filtertasche**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sprechventil rund für Silber Innenkanüle mit Filtertasche**</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:24.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290122</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Sprechschiebeventil Gr 08-12**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:23.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290115</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Sprechschiebeventil Gr 05-07**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>173001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:22.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290108</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Aufsatz mit Sprechschiebeventil**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1726VS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:21.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290092</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Aufsatz mit rundem Sprechventil**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1726VR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:20.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290085</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Adapter mit Sprechventil und Filtertasche**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1726VF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:19.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260741290078</udiDi>
    <basicUdiDi>426074129Ventil6K</basicUdiDi>
    <tradeName>Sprechventil eckig für Silber Innenkanüle Gr. 08-12**</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900602</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1722V02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:10:19.087Z</lastUpdated>
  </row>
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