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    <tradeName>TRACHEOSTOMY TUBE-CUFFED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:00.351Z</lastUpdated>
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    <udiDi>04250203264631</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 10, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.383Z</lastUpdated>
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    <udiDi>04250203264662</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 7, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.371Z</lastUpdated>
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    <udiDi>04250203264693</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 8, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.362Z</lastUpdated>
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    <udiDi>04250203264723</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 9, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.348Z</lastUpdated>
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  <row>
    <udiDi>04250203264754</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 10, gefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.334Z</lastUpdated>
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  <row>
    <udiDi>04250203264785</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 7, gefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012270</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203264815</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 8, gefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012280</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203264846</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine XT Gr. 9, gefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012290</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:04.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203266031</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle Optima/Ultrasoft Gr.6 transparent</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102018-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.715Z</lastUpdated>
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  <row>
    <udiDi>04250203266062</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle Optima/Ultrasoft Gr.7 transparent</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102019-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203266093</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle Optima/Ultrasoft Gr.6 rot</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102028-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203266123</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle Optima/Ultrasoft Gr.7 rot</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102029-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.667Z</lastUpdated>
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  <row>
    <udiDi>04250203266154</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle Optima/Ultrasoft Gr.6 weiß</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102038-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.648Z</lastUpdated>
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  <row>
    <udiDi>04250203266185</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle Optima/Ultrasoft Gr.7 weiß</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102039-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.626Z</lastUpdated>
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  <row>
    <udiDi>04250203266215</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine Gr. 10, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011110-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203266246</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine Gr. 6, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011160-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203266277</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine Gr. 7, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011170-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203266307</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine Gr. 8, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011180-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.543Z</lastUpdated>
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  <row>
    <udiDi>04250203266338</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle ProLine Gr. 9, ungefenstert,</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011190-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:03.524Z</lastUpdated>
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