<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05901292127862</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-9555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:37:26.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704203697</udiDi>
    <basicUdiDi>B-04026704203697</basicUdiDi>
    <tradeName>Rusch Tracheofix TF, Set PVC</tradeName>
    <deviceName>TRACHEOSTOMY CANNULA SET</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121415-000085</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:12:28.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127855</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-9055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:46:58.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127848</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-8555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:39:16.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127831</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-8055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:35:19.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127824</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-7555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:31:41.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127817</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-7055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:24:16.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224314</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.13, gesiebt, überlang, L = 130 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>201553</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:23:10.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127800</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-6555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:18:49.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224307</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.12, gesiebt, überlang, L = 125 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>201552</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:17:43.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127794</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-6055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:15:38.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224291</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.11, gesiebt, überlang, L = 120 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>201551</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:14:31.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127787</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-5555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:11:04.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224284</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.10, gesiebt, überlang, L = 115 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>201550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:09:56.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127770</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-5055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:06:03.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224277</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.9, gesiebt, überlang, L = 110 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>201549</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:04:45.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127763</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-4555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T18:59:17.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224260</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.8, gesiebt, überlang, L = 105 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>201548</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T18:58:07.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292127756</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>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34-4055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-06T18:52:10.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203224253</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.7, gesiebt, überlang, L = 100 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>201547</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T18:51:00.394Z</lastUpdated>
  </row>
</eudamedExport>