<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04048675041146</udiDi>
    <basicUdiDi>B-04048675041146</basicUdiDi>
    <tradeName>NovaStar® TS NIV-Maske,AAV,S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MP01576</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:54:02.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675040569</udiDi>
    <basicUdiDi>B-04048675040569</basicUdiDi>
    <tradeName>NovaStar® TS NIV-Maske,SE,M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01580</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:54:00.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675040552</udiDi>
    <basicUdiDi>B-04048675040552</basicUdiDi>
    <tradeName>NovaStar® TS NIV-Maske,SE,S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01579</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:53:56.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675040545</udiDi>
    <basicUdiDi>B-04048675040545</basicUdiDi>
    <tradeName>Kopfband f.NovaStar TS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MP01583</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:53:55.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675040538</udiDi>
    <basicUdiDi>B-04048675040538</basicUdiDi>
    <tradeName>NovaStar® TS NIV-Maske,SE,L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01581</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:53:54.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028799</udiDi>
    <basicUdiDi>B-00813830028799</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33037-17-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:54:07.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028782</udiDi>
    <basicUdiDi>B-00813830028782</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33037-12-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:54:06.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028775</udiDi>
    <basicUdiDi>B-00813830028775</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33037-11-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:54:05.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028768</udiDi>
    <basicUdiDi>B-00813830028768</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33037-10-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:54:04.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028751</udiDi>
    <basicUdiDi>B-00813830028751</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33037-9-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:54:00.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028744</udiDi>
    <basicUdiDi>B-00813830028744</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33035-16-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:54:00.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028737</udiDi>
    <basicUdiDi>B-00813830028737</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33035-14-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:59.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028720</udiDi>
    <basicUdiDi>B-00813830028720</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33035-12-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:58.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028713</udiDi>
    <basicUdiDi>B-00813830028713</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33035-10-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:54.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028706</udiDi>
    <basicUdiDi>B-00813830028706</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33035-9-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:53.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028690</udiDi>
    <basicUdiDi>B-00813830028690</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33034-16-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:52.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028683</udiDi>
    <basicUdiDi>B-00813830028683</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33034-14-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:52.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028676</udiDi>
    <basicUdiDi>B-00813830028676</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33034-10-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:48.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830028669</udiDi>
    <basicUdiDi>B-00813830028669</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33034-9-CAP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:47.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813830026825</udiDi>
    <basicUdiDi>B-00813830026825</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28534</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:53:00.731Z</lastUpdated>
  </row>
</eudamedExport>