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<eudamedExport entity="devices">
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    <udiDi>04716770292007</udiDi>
    <basicUdiDi>4716770PF02900G7</basicUdiDi>
    <tradeName>Peak flow meter-low range 50-300 L/min</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-29200</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:12.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770292106</udiDi>
    <basicUdiDi>4716770PF02900G7</basicUdiDi>
    <tradeName>Cardboard Mouthpiece with One-Way Valve, Pediatric</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-29210</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:12.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770292113</udiDi>
    <basicUdiDi>4716770PF02900G7</basicUdiDi>
    <tradeName>Durable Mouthpiece with One-Way Valve, Pediatric</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-29211</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:12.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770935003</udiDi>
    <basicUdiDi>4716770TB09300HA</basicUdiDi>
    <tradeName>Volumeteric Incentive Spirometer 5000 ml</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-93500</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:10.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613365002881</udiDi>
    <basicUdiDi>B-07613365002881</basicUdiDi>
    <tradeName>SPIROVIT SP-1 G2</tradeName>
    <deviceName>SPIROVIT SP-1 G2</deviceName>
    <manufacturerName>SCHILLER AG</manufacturerName>
    <manufacturerSrn>CH-MF-000012722</manufacturerSrn>
    <authorisedRepresentativeName>SCHILLER Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006934</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.911120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:49:37.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350002630051</udiDi>
    <basicUdiDi>B-07350002630051</basicUdiDi>
    <tradeName>NuvoAir Home</tradeName>
    <deviceName>NuvoAir Home</deviceName>
    <manufacturerName>NuvoAir AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005645</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVH-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:27.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350002630020</udiDi>
    <basicUdiDi>B-07350002630020</basicUdiDi>
    <tradeName>Air Next</tradeName>
    <deviceName>Air Next Spirometer</deviceName>
    <manufacturerName>NuvoAir AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005645</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NVD-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:25.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110070373</udiDi>
    <basicUdiDi>B-07290110070373</basicUdiDi>
    <tradeName>ReDS Pro</tradeName>
    <deviceName>ReDS Pro System-Refurbished</deviceName>
    <manufacturerName>Sensible Medical Innovations Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000029801</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159007</emdnCode>
    <emdnDescription>BODY PLETHYSMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAS0027-R</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:42:33.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110070298</udiDi>
    <basicUdiDi>B-07290110070298</basicUdiDi>
    <tradeName>ReDS Pro</tradeName>
    <deviceName>ReDS Pro System</deviceName>
    <manufacturerName>Sensible Medical Innovations Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000029801</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159007</emdnCode>
    <emdnDescription>BODY PLETHYSMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAS0027</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:42:29.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973632410100</udiDi>
    <basicUdiDi>B-06973632410100</basicUdiDi>
    <tradeName>Oxygen concentrator</tradeName>
    <deviceName>Oxygen Concentrator</deviceName>
    <manufacturerName>Oxytek Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022935</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX-1A-E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:22:31.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971882890437</udiDi>
    <basicUdiDi>B-06971882890437</basicUdiDi>
    <tradeName>PORTABLE OXYGEN CONCENTRATOR</tradeName>
    <deviceName>Portable Oxygen Concentrator</deviceName>
    <manufacturerName>Qingdao Kingon Medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018407</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:58:21.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971072050085</udiDi>
    <basicUdiDi>B-06971072050085</basicUdiDi>
    <tradeName>Care</tradeName>
    <deviceName>Oxygen Concentrator</deviceName>
    <manufacturerName>Foshan Care Medical Technology Co. Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018871</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY-5AF</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:07:45.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>05998177100027</udiDi>
    <basicUdiDi>59981771000000000000001DX</basicUdiDi>
    <tradeName>BÉABA MINIDOO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rokána Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000048032</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:02.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>05998177100034</udiDi>
    <basicUdiDi>59981771000000000000001DX</basicUdiDi>
    <tradeName>TOMYKA MINIDOO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rokána Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000048032</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:02.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>05998177100041</udiDi>
    <basicUdiDi>59981771000000000000001DX</basicUdiDi>
    <tradeName>NANNY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rokána Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000048032</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>004</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:02.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407003169010</udiDi>
    <basicUdiDi>B-05407003169010</basicUdiDi>
    <tradeName>BTL FeNO+</tradeName>
    <deviceName>BTL FeNO+</deviceName>
    <manufacturerName>Medisoft S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000000789</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159006</emdnCode>
    <emdnDescription>EXPIRATED GAS ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FE-00-01-BTL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:31:53.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407003168020</udiDi>
    <basicUdiDi>B-05407003168020</basicUdiDi>
    <tradeName>BTL Micro 6000</tradeName>
    <deviceName>BTL Micro 6000</deviceName>
    <manufacturerName>Medisoft S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000000789</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-00-09-BTL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:31:53.314Z</lastUpdated>
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  <row>
    <udiDi>05407003167023</udiDi>
    <basicUdiDi>B-05407003167023</basicUdiDi>
    <tradeName>BTL Micro 5000</tradeName>
    <deviceName>BTL Micro 5000</deviceName>
    <manufacturerName>Medisoft S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000000789</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-00-01-BTL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:31:48.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407003166026</udiDi>
    <basicUdiDi>B-05407003166026</basicUdiDi>
    <tradeName>BTL HypAir</tradeName>
    <deviceName>BTL HypAir</deviceName>
    <manufacturerName>Medisoft S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000000789</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159008</emdnCode>
    <emdnDescription>PNEUMOTACHOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-00-01-BTL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:31:46.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407003165029</udiDi>
    <basicUdiDi>B-05407003165029</basicUdiDi>
    <tradeName>BTL Ergocard CPX Professional</tradeName>
    <deviceName>BTL Ergocard CPX Professional</deviceName>
    <manufacturerName>Medisoft S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000000789</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159006</emdnCode>
    <emdnDescription>EXPIRATED GAS ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER-10-01-BTL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:31:46.126Z</lastUpdated>
  </row>
</eudamedExport>