<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04716770636245</udiDi>
    <basicUdiDi>B-04716770636245</basicUdiDi>
    <tradeName>FitMax® CPAP Total Face Mask</tradeName>
    <deviceName>FitMax Reusable CPAP Total Face Mask with Standard Elbow, Anti-Asphyxia Elbow, Size L</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63624</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:13.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770636238</udiDi>
    <basicUdiDi>B-04716770636238</basicUdiDi>
    <tradeName>FitMax® CPAP Total Face Mask</tradeName>
    <deviceName>FitMax Reusable CPAP Total Face Mask with Standard Elbow, Anti-Asphyxia Elbow, Size M</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63623</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:12.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770636221</udiDi>
    <basicUdiDi>B-04716770636221</basicUdiDi>
    <tradeName>FitMax® CPAP Total Face Mask</tradeName>
    <deviceName>FitMax Reusable CPAP Total Face Mask with Standard Elbow, Anti-Asphyxia Elbow, and Corrugate Tube, Size S</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63622</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:08.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770636214</udiDi>
    <basicUdiDi>B-04716770636214</basicUdiDi>
    <tradeName>FitMax® CPAP Total Face Mask</tradeName>
    <deviceName>FitMax Reusable CPAP Total Face Mask with Standard Elbow, Anti-Asphyxia Elbow and Corrugate Tube, Size XS</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63621</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:07.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770626253</udiDi>
    <basicUdiDi>B-04716770626253</basicUdiDi>
    <tradeName>Oxygen Reservoir, 2500ml</tradeName>
    <deviceName>Oxygen Reservoir, 2500ml</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR-62625</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:07.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770626109</udiDi>
    <basicUdiDi>B-04716770626109</basicUdiDi>
    <tradeName>Oxygen Reservoir, 1000ml</tradeName>
    <deviceName>Oxygen reservoir 1000ml</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR-62610</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:06.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770311005</udiDi>
    <basicUdiDi>B-04716770311005</basicUdiDi>
    <tradeName>Disposable Nebulizer Bottle, OD: 18mm</tradeName>
    <deviceName>Disposable Nebulizer, OD: 18mm</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31100</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:01.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770246239</udiDi>
    <basicUdiDi>B-04716770246239</basicUdiDi>
    <tradeName>SINGLE USE INFANT 280ML RESUSCITATOR W/POP-OFF 40CM H2O</tradeName>
    <deviceName>SINGLE USE INFANT 280ML RESUSCITATOR W/POP-OFF 40CM H2O</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24623</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:56:00.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770245232</udiDi>
    <basicUdiDi>B-04716770245232</basicUdiDi>
    <tradeName>SINGLE USE CHILD 550ML RESUSCITATOR W/POP-OFF 40CM H2O</tradeName>
    <deviceName>SINGLE USE CHILD 550ML RESUSCITATOR W/POP-OFF 40CM H2O</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24523</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:55:59.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770244389</udiDi>
    <basicUdiDi>B-04716770244389</basicUdiDi>
    <tradeName>Single Use Resuscitator with Handstrap, 60cmH2O POP-OFF, 1600ml, Adult</tradeName>
    <deviceName>Single Use Resuscitator with Handstrap, 60cmH2O POP-OFF, 1600ml, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24438</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:55:59.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770244372</udiDi>
    <basicUdiDi>B-04716770244372</basicUdiDi>
    <tradeName>Single use resuscitator 1600 ml W/ 60 cmH2O POP-OFF (W/O MDI port), Oxygen tubing (2.0 m), Air cushion mask (size 5), Oxygen reservoir (2500 ml), Adult</tradeName>
    <deviceName>Single use resuscitator 1600 ml W/ 60 cmH2O POP-OFF (W/O MDI port), Oxygen tubing (2.0 m), Air cushion mask (size 5), Oxygen reservoir (2500 ml), Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24437</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:55:55.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770233307</udiDi>
    <basicUdiDi>B-04716770233307</basicUdiDi>
    <tradeName>Reusable Resuscitator 280 ml W/ 40 cm H2O POP-OFF</tradeName>
    <deviceName>Reusable Resuscitator 280 ml W/ 40 cm H2O POP-OFF</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-23330</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:55:54.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770232300</udiDi>
    <basicUdiDi>B-04716770232300</basicUdiDi>
    <tradeName>Reusable Resuscitator 500 ml W/ 40 cm H2O POP-OFF</tradeName>
    <deviceName>Reusable Resuscitator 500 ml W/ 40 cm H2O POP-OFF</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-23230</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:55:53.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770231501</udiDi>
    <basicUdiDi>B-04716770231501</basicUdiDi>
    <tradeName>Reusable Resuscitator 1700 ml, Adult</tradeName>
    <deviceName>Reusable Resuscitator 1700 ml, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-23150</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:55:52.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770211657</udiDi>
    <basicUdiDi>B-04716770211657</basicUdiDi>
    <tradeName>Non-rebreathing Valve Complete with 60cmH2O</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-21165</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:53:50.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770211527</udiDi>
    <basicUdiDi>B-04716770211527</basicUdiDi>
    <tradeName>Non-Rebreathing Valve with Manometer Port L Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-21152</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:53:49.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713025001001</udiDi>
    <basicUdiDi>B-04713025001001</basicUdiDi>
    <tradeName>WiZARD 520</tradeName>
    <deviceName>Full Face Mask</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM12001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:49:51.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182607135</udiDi>
    <basicUdiDi>B-04711182607135</basicUdiDi>
    <tradeName>Neck Strap</tradeName>
    <deviceName>Neck Strap</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1550-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:16:50.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604561</udiDi>
    <basicUdiDi>B-04711182604561</basicUdiDi>
    <tradeName>Guedel Airway</tradeName>
    <deviceName>Guedel Airway</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010102</emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1603-0090</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:52.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603151</udiDi>
    <basicUdiDi>B-04711182603151</basicUdiDi>
    <tradeName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</tradeName>
    <deviceName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0050</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:46.941Z</lastUpdated>
  </row>
</eudamedExport>