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<eudamedExport entity="devices">
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    <udiDi>05707480037254</udiDi>
    <basicUdiDi>570748030101031006K</basicUdiDi>
    <tradeName>Ambu® Oval Plus Silicone Resuscitator</tradeName>
    <deviceName>Ambu® Oval Plus Silicone Resuscitator</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-PR-000001946</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A288104000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:06:08.081Z</lastUpdated>
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  <row>
    <udiDi>05707480037223</udiDi>
    <basicUdiDi>5707480301005501089</basicUdiDi>
    <tradeName>Ambu® Oval Plus Silicone Resuscitator</tradeName>
    <deviceName>Oval Plus Silicone Resuscitator, Reservoir Tube</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A288101000</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:06:07.958Z</lastUpdated>
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  <row>
    <udiDi>05707480035199</udiDi>
    <basicUdiDi>570748030101051006Z</basicUdiDi>
    <tradeName>Ambu® Mark IV</tradeName>
    <deviceName>Ambu® Mark IV</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-PR-000001946</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>299001000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:06:06.527Z</lastUpdated>
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    <udiDi>05707480032471</udiDi>
    <basicUdiDi>5707480301005401082</basicUdiDi>
    <tradeName>Ambu® SPUR® II</tradeName>
    <deviceName>SPUR II Reservoir Bag</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325001000</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:06:01.605Z</lastUpdated>
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  <row>
    <udiDi>05707480021567</udiDi>
    <basicUdiDi>570748030101001005W</basicUdiDi>
    <tradeName>Ambu® SPUR® II</tradeName>
    <deviceName>SPUR Mask</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-PR-000001946</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>335102000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:05:45.594Z</lastUpdated>
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  <row>
    <udiDi>04250105628593</udiDi>
    <basicUdiDi>42501056-1.4.4-VM</basicUdiDi>
    <tradeName>Reservoir Bag 2500 ml</tradeName>
    <deviceName>Resuscitators - Acc. Resuscitators</deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89-12-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:45:44.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250105628470</udiDi>
    <basicUdiDi>42501056-1.4.1-VC</basicUdiDi>
    <tradeName>Silicone Resuscitator Set; for adult Silicone Resuscitator Bag: 1500 ml; &gt; 20 kg; Reservoir Bag: 2500 ml; Mask: #5</tradeName>
    <deviceName>Resuscitators - Silicone Resuscitators</deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-10-190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:45:43.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250105619584</udiDi>
    <basicUdiDi>42501056-1.4.3-VJ</basicUdiDi>
    <tradeName>PVC Resuscitator Set for infant Resuscitation bag: 280 ml, Reservoir bag: 600 ml ; &lt; 5 kg ; Mask: #1</tradeName>
    <deviceName>Resuscitators - PVC Resuscitators</deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-10-395</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:45:42.461Z</lastUpdated>
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  <row>
    <udiDi>10641043572030</udiDi>
    <basicUdiDi>0641043FLMU</basicUdiDi>
    <tradeName>Flow-Safe II</tradeName>
    <deviceName>Flow-Safe II</deviceName>
    <manufacturerName>Mercury Medical</manufacturerName>
    <manufacturerSrn>US-MF-000002015</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-57203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:11:24.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>10641043558003</udiDi>
    <basicUdiDi>0641043HYNU</basicUdiDi>
    <tradeName>Hyperinflation</tradeName>
    <deviceName>Hyperinflation System</deviceName>
    <manufacturerName>Mercury Medical</manufacturerName>
    <manufacturerSrn>US-MF-000002015</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-55800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:11:22.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>10641043541081</udiDi>
    <basicUdiDi>0641043CPMT</basicUdiDi>
    <tradeName>Disposable Manual Resuscitator</tradeName>
    <deviceName>Adult CPR Bag</deviceName>
    <manufacturerName>Mercury Medical</manufacturerName>
    <manufacturerSrn>US-MF-000002015</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-54108</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:11:18.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>10641043508022</udiDi>
    <basicUdiDi>0641043NEN6</basicUdiDi>
    <tradeName>Neo-Tee</tradeName>
    <deviceName>Neo-Tee T-Piece Resuscitator</deviceName>
    <manufacturerName>Mercury Medical</manufacturerName>
    <manufacturerSrn>US-MF-000002015</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-50802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:11:14.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>10641043507001</udiDi>
    <basicUdiDi>0641043CRMX</basicUdiDi>
    <tradeName>10641043507001</tradeName>
    <deviceName>Reusable CPR Bag</deviceName>
    <manufacturerName>Mercury Medical</manufacturerName>
    <manufacturerSrn>US-MF-000002015</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-50700</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:11:13.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RE-24320YM</udiDi>
    <basicUdiDi>B-RE-24320YM</basicUdiDi>
    <tradeName>D-RE-24320YM</tradeName>
    <deviceName>Silicone Infant Resuscitator 280ml W/ 40 cmH2O POP-OFF</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:55.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RE-24220YG</udiDi>
    <basicUdiDi>B-RE-24220YG</basicUdiDi>
    <tradeName>D-RE-24220YG</tradeName>
    <deviceName>Silicone Child Resuscitator 500ml W/ 40 cmH2O POP-OFF</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:54.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RE-24140YH</udiDi>
    <basicUdiDi>B-RE-24140YH</basicUdiDi>
    <tradeName>D-RE-24140YH</tradeName>
    <deviceName>Silicone Adult Resuscitator 1600ml W/ 60 cmH2O POP-OFF</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:53.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RE-24120YB</udiDi>
    <basicUdiDi>B-RE-24120YB</basicUdiDi>
    <tradeName>D-RE-24120YB</tradeName>
    <deviceName>Silicone Adult Resuscitator 1600 ml W/O POP-OFF</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-24120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:52.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RE-23610YS</udiDi>
    <basicUdiDi>B-RE-23610YS</basicUdiDi>
    <tradeName>D-RE-23610YS</tradeName>
    <deviceName>SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40 CMH2O (ALL IN ONE-INTAKE VALVE)</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-23610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:47.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RE-23510YM</udiDi>
    <basicUdiDi>B-RE-23510YM</basicUdiDi>
    <tradeName>D-RE-23510YM</tradeName>
    <deviceName>SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40 CMH2O (ALL IN ONE-INTAKE VALVE)</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-23510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:47.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RE-23420YK</udiDi>
    <basicUdiDi>B-RE-23420YK</basicUdiDi>
    <tradeName>D-RE-23420YK</tradeName>
    <deviceName>SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60 CMH2O (ALL IN ONE-INTAKE VALVE)</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE-23420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:46.203Z</lastUpdated>
  </row>
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