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<eudamedExport entity="devices">
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    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.7, L = 65 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200114 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:43:56.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131098</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-5500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:40:48.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203236348</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.6, L = 60 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200113 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:39:49.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131081</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-5000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:37:00.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203236317</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.5, L = 57 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200112 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:35:55.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131074</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-4500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:33:00.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203236287</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.4, L = 55 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200111 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:31:56.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131067</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-4000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:28:39.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203236256</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.3,5, L = 55 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200110 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:27:32.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131050</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-3500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:24:44.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131043</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-3000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:21:31.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131036</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-2500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:17:03.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131012</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3N-4000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:12:38.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292131005</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3N-3500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:10:03.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292130992</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3N-3000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:05:21.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292130985</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna SUMINI bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3N-2500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T01:00:55.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292129255</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010202</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38-1017</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T00:56:15.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292129248</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010202</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38-9017</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T00:53:55.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292129231</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010202</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38-8017</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T00:49:18.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292129224</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010202</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38-7017</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T00:44:47.178Z</lastUpdated>
  </row>
</eudamedExport>