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    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDI-PHON PLUS® (transparent) Sprechventil für Tracheotomierte,</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>200354</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:50.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203214247</udiDi>
    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDI-PHON PLUS® (blau-transparent) Sprechventil für Tracheotomierte,</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>200356</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:50.175Z</lastUpdated>
  </row>
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    <udiDi>04250203214254</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>PRIMEDI-PHON PLUS® (blau-transparent, O2-Anschluss) Sprechventil für Tracheotomierte,</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>200357</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:50.157Z</lastUpdated>
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  <row>
    <udiDi>04250203220149</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>PRIMEDI-PHON VENT® (PPV) Sprechventil für beatmete, tracheotomierte Patienten</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 FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:38.402Z</lastUpdated>
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  <row>
    <udiDi>04250203220910</udiDi>
    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDI-RESISTANCE VALVE Sprechventil für Laryngektomierte &amp; Tracheotomierte,</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>20481</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.688Z</lastUpdated>
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  <row>
    <udiDi>04250203220927</udiDi>
    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDI-LOW-RESISTANCE VALVE Sprechventil für Laryngektomierte &amp; Tracheotomierte</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>20480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221078</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>PRIMEDI-PHON PLUS® (blau-transparent) mit O2 Anschluss Sprechventil für Anschluß an 15 mm und 22mm Systeme</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>200321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640465</udiDi>
    <basicUdiDi>506041364TF013W3</basicUdiDi>
    <tradeName>Tracheostomy Speaking Valve (White)</tradeName>
    <deviceName>Tracheostomy Speaking Valve</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/100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:11.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203243377</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>TwinPhon® Extra mit 5x HME Filterkassette</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>200318</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:30.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203243391</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>TwinPhon® 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>200319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:30.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203254922</udiDi>
    <basicUdiDi>42502032PRI0274U</basicUdiDi>
    <tradeName>HME Filterkassette für TwinPhon®</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>200317</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:08.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203254960</udiDi>
    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDIAIR®-PHON ULTRAFLOW, Sprechventil mit Filterfunktion (Schachtel mit 6 Beutel a 5 Stück), 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>200359</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:08.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203256773</udiDi>
    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDI Sprechventil Sprechventil für Tracheotomierte,</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>20489</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:07.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203272636</udiDi>
    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -PHON Sprechventil mit Filterfunktion</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>20483</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:01.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203273619</udiDi>
    <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>
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  <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>
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  <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>
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