<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>04711182603144</udiDi>
    <basicUdiDi>B-04711182603144</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>1580-0040</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:46.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603137</udiDi>
    <basicUdiDi>B-04711182603137</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>1580-0030</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:45.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603120</udiDi>
    <basicUdiDi>B-04711182603120</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0025</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:41.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603113</udiDi>
    <basicUdiDi>B-04711182603113</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>1580-0020</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:40.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603106</udiDi>
    <basicUdiDi>B-04711182603106</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>1580-0015</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:39.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603052</udiDi>
    <basicUdiDi>B-04711182603052</basicUdiDi>
    <tradeName>Teeth Opener</tradeName>
    <deviceName>Teeth Opener</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>R030280</emdnCode>
    <emdnDescription>RESPIRATORY BALLONS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1607-9001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:12:34.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931522</udiDi>
    <basicUdiDi>B-04710961931522</basicUdiDi>
    <tradeName>Air-Cush Mask</tradeName>
    <deviceName>Air-Cush Mask</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>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1691-9005</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:53.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931515</udiDi>
    <basicUdiDi>B-04710961931515</basicUdiDi>
    <tradeName>Air-Cush Mask</tradeName>
    <deviceName>Air-Cush Mask</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>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1691-9005</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:52.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931508</udiDi>
    <basicUdiDi>B-04710961931508</basicUdiDi>
    <tradeName>Air-Cush Mask</tradeName>
    <deviceName>Air-Cush Mask</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>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1691-9003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:51.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931492</udiDi>
    <basicUdiDi>B-04710961931492</basicUdiDi>
    <tradeName>Air-Cush Mask</tradeName>
    <deviceName>Air-Cush Mask</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>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1691-9002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:47.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931485</udiDi>
    <basicUdiDi>B-04710961931485</basicUdiDi>
    <tradeName>Air-Cush Mask</tradeName>
    <deviceName>Air-Cush Mask</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>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1691-9001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:46.754Z</lastUpdated>
  </row>
</eudamedExport>