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<eudamedExport entity="devices">
  <row>
    <udiDi>04710961931355</udiDi>
    <basicUdiDi>B-04710961931355</basicUdiDi>
    <tradeName>Silicone Mask</tradeName>
    <deviceName>Silicone 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>1611-9000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:38.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931348</udiDi>
    <basicUdiDi>B-04710961931348</basicUdiDi>
    <tradeName>PVC Resuscitator</tradeName>
    <deviceName>PVC Resuscitator</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1690-0003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:34.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931331</udiDi>
    <basicUdiDi>B-04710961931331</basicUdiDi>
    <tradeName>PVC Resuscitator</tradeName>
    <deviceName>PVC Resuscitator</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1690-0002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:33.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931324</udiDi>
    <basicUdiDi>B-04710961931324</basicUdiDi>
    <tradeName>PVC Resuscitator</tradeName>
    <deviceName>PVC Resuscitator</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1690-0001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:33.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931287</udiDi>
    <basicUdiDi>B-04710961931287</basicUdiDi>
    <tradeName>Silicone Resuscitator</tradeName>
    <deviceName>Silicone Resuscitator</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1610-0003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:32.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931133</udiDi>
    <basicUdiDi>B-04710961931133</basicUdiDi>
    <tradeName>Silicone Tracheostomy Tube, Low Pressure Cuff</tradeName>
    <deviceName>Silicone Tracheostomy Tube, Low Pressure Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1565-0100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:28.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931126</udiDi>
    <basicUdiDi>B-04710961931126</basicUdiDi>
    <tradeName>Silicone Tracheostomy Tube, Low Pressure Cuff</tradeName>
    <deviceName>Silicone Tracheostomy Tube, Low Pressure Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1565-0090</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:27.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931119</udiDi>
    <basicUdiDi>B-04710961931119</basicUdiDi>
    <tradeName>Silicone Tracheostomy Tube, Low Pressure Cuff</tradeName>
    <deviceName>Silicone Tracheostomy Tube, Low Pressure Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1565-0080</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:12.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931102</udiDi>
    <basicUdiDi>B-04710961931102</basicUdiDi>
    <tradeName>Silicone Tracheostomy Tube, Low Pressure Cuff</tradeName>
    <deviceName>Silicone Tracheostomy Tube, Low Pressure Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1565-0070</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:11.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931096</udiDi>
    <basicUdiDi>B-04710961931096</basicUdiDi>
    <tradeName>Silicone Tracheostomy Tube, Low Pressure Cuff</tradeName>
    <deviceName>Silicone Tracheostomy Tube, Low Pressure Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1565-0060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:10.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931089</udiDi>
    <basicUdiDi>B-04710961931089</basicUdiDi>
    <tradeName>Silicone Tracheostomy Tube, Low Pressure Cuff</tradeName>
    <deviceName>Silicone Tracheostomy Tube, Low Pressure Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1565-0050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:09.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931041</udiDi>
    <basicUdiDi>B-04710961931041</basicUdiDi>
    <tradeName>Slllcone Tracheostomy Tube</tradeName>
    <deviceName>Slllcone Tracheostomy Tube</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1561-0070</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:05.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931003</udiDi>
    <basicUdiDi>B-04710961931003</basicUdiDi>
    <tradeName>Slllcone Tracheostomy Tube, Ordinary Cuff</tradeName>
    <deviceName>Slllcone Tracheostomy Tube, Ordinary Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1560-0090</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:05.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930990</udiDi>
    <basicUdiDi>B-04710961930990</basicUdiDi>
    <tradeName>Slllcone Tracheostomy Tube, Ordinary Cuff</tradeName>
    <deviceName>Slllcone Tracheostomy Tube, Ordinary Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1560-0080</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:04.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930983</udiDi>
    <basicUdiDi>B-04710961930983</basicUdiDi>
    <tradeName>Slllcone Tracheostomy Tube, Ordinary Cuff</tradeName>
    <deviceName>Slllcone Tracheostomy Tube, Ordinary Cuff</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1560-0070</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:03.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930914</udiDi>
    <basicUdiDi>B-04710961930914</basicUdiDi>
    <tradeName>Sillcone Endotracheal Tube</tradeName>
    <deviceName>Sillcone Endotracheal Tube</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>R01030202</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1555-0080</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:00.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930907</udiDi>
    <basicUdiDi>B-04710961930907</basicUdiDi>
    <tradeName>Sillcone Endotracheal Tube</tradeName>
    <deviceName>Sillcone Endotracheal Tube</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>R01030202</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1555-0075</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:01:58.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930891</udiDi>
    <basicUdiDi>B-04710961930891</basicUdiDi>
    <tradeName>Sillcone Endotracheal Tube</tradeName>
    <deviceName>Sillcone Endotracheal Tube</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>R01030202</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1555-0070</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:01:57.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160150</udiDi>
    <basicUdiDi>697551916NOCV8</basicUdiDi>
    <tradeName>Disposable Nasal Oxygen Cannula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Adult-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:05:31.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519160160</udiDi>
    <basicUdiDi>697551916NOCV8</basicUdiDi>
    <tradeName>06975519160160</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Infant-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:05:27.744Z</lastUpdated>
  </row>
</eudamedExport>