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<eudamedExport entity="devices">
  <row>
    <udiDi>00818806021002</udiDi>
    <basicUdiDi>0818806020028H</basicUdiDi>
    <tradeName>Light Delivery Device</tradeName>
    <deviceName>Light Delivery Device</deviceName>
    <manufacturerName>RxSight, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010449</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61002-007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:32:44.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501023295</udiDi>
    <basicUdiDi>081850102Extnasalband3F</basicUdiDi>
    <tradeName>External Nasal Bandage</tradeName>
    <deviceName>External Nasal Bandage</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-10610</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:32:17.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501022892</udiDi>
    <basicUdiDi>081850102EarDressingAS</basicUdiDi>
    <tradeName>00818501022892</tradeName>
    <deviceName>Ear Protector, Hard Cup</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-15005</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:32:16.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501022694</udiDi>
    <basicUdiDi>081850102PVAWipeSC</basicUdiDi>
    <tradeName>00818501022694</tradeName>
    <deviceName>PVA Instrument Wipe - Accessory</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22-70300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:32:00.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501022434</udiDi>
    <basicUdiDi>081850102ExtNasalSplintRD</basicUdiDi>
    <tradeName>Soft-Form™ Thermo Plastic</tradeName>
    <deviceName>External Nasal Splint</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-10100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:57.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501022397</udiDi>
    <basicUdiDi>081850102ScopeCoverAQ</basicUdiDi>
    <tradeName>ClearView™ Scope Cover</tradeName>
    <deviceName>ClearView™ Scope Cover Adult Flexible Endoscope Cover</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28-36000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:56.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501021925</udiDi>
    <basicUdiDi>081850102PVAPackingYA</basicUdiDi>
    <tradeName>00818501021925</tradeName>
    <deviceName>PVA Packing</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22-60108</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:55.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501021345</udiDi>
    <basicUdiDi>081850102ENTBursN5</basicUdiDi>
    <tradeName>00818501021345</tradeName>
    <deviceName>ENT Bur</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-70050</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:53.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501021161</udiDi>
    <basicUdiDi>081850102NSSiliconePB</basicUdiDi>
    <tradeName>00818501021161</tradeName>
    <deviceName>Silicone Sheeting - Non-Sterile</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-20680</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:51.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501021116</udiDi>
    <basicUdiDi>081850102NSSiliconetubeVL</basicUdiDi>
    <tradeName>00818501021116</tradeName>
    <deviceName>Silicone Tubing - Non-Sterile</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-01151</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:49.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501021109</udiDi>
    <basicUdiDi>081850102TeethprotectorT4</basicUdiDi>
    <tradeName>00818501021109</tradeName>
    <deviceName>Teeth Protector</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L96050</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:48.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501020867</udiDi>
    <basicUdiDi>081850102SiliconeSheetSV</basicUdiDi>
    <tradeName>00818501020867</tradeName>
    <deviceName>Otology Packing Strips - Silicone</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27-10000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:47.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501020751</udiDi>
    <basicUdiDi>081850102IntNasalSplintHX</basicUdiDi>
    <tradeName>Breath-Easy</tradeName>
    <deviceName>Internal Nasal Splint</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-10500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:44.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501020669</udiDi>
    <basicUdiDi>081850102EpistaxisPack5V</basicUdiDi>
    <tradeName>Ultra-Stat Epistaxis Nasal Balloon</tradeName>
    <deviceName>Epistaxis Nasal Balloon</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-10700</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:43.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501020058</udiDi>
    <basicUdiDi>081850102TrachealtubeQG</basicUdiDi>
    <tradeName>00818501020058</tradeName>
    <deviceName>Tracheal T-Tube</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70-50080</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:42.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501020027</udiDi>
    <basicUdiDi>081850102LaryElectrodeFY</basicUdiDi>
    <tradeName>00818501020027</tradeName>
    <deviceName>Invotec Surface Electrode</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29-80500S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:40.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818501020003</udiDi>
    <basicUdiDi>081850102SeptalButtonW9</basicUdiDi>
    <tradeName>00818501020003</tradeName>
    <deviceName>Nasal Septal Button</deviceName>
    <manufacturerName>Invotec International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024855</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-10400</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:31:38.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262512210575</udiDi>
    <basicUdiDi>0426251221ERBUX</basicUdiDi>
    <tradeName>Ear rinsing bowl</tradeName>
    <deviceName>Ear rinsing bowl</deviceName>
    <manufacturerName>Heinemann HNO Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000046391</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0130-50500 / 12-3104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:40:44.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262512210377</udiDi>
    <basicUdiDi>0426251221NCCUZ</basicUdiDi>
    <tradeName>Nebulizer for powder complete with bottle</tradeName>
    <deviceName>Nebulizer</deviceName>
    <manufacturerName>Heinemann HNO Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000046391</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5140-60102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:40:43.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260548933000</udiDi>
    <basicUdiDi>0426054893MOD3K</basicUdiDi>
    <tradeName>ENT treatment unit MODULA Paris</tradeName>
    <deviceName>ENT treatment unit MODULA</deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0100-20000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:40:37.557Z</lastUpdated>
  </row>
</eudamedExport>