<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06923980106903</udiDi>
    <basicUdiDi>69239801ND1DANJ</basicUdiDi>
    <tradeName>Nose Clip</tradeName>
    <deviceName>Nose Clip</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL0010</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:07.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959005211</udiDi>
    <basicUdiDi>B-00606959005211</basicUdiDi>
    <tradeName>Trilogy Active Flow Exhalation Circuit Adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1068837</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:07.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321964</udiDi>
    <basicUdiDi>805299032MOVN</basicUdiDi>
    <tradeName>Plastic Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910307</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:40:07.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321896</udiDi>
    <basicUdiDi>805299032014DH</basicUdiDi>
    <tradeName>Reusable Turbine PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>913002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:40:05.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321742</udiDi>
    <basicUdiDi>805299032SPRTPMRU</basicUdiDi>
    <tradeName>Single patient reusable turbine with plastic mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:40:03.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321261</udiDi>
    <basicUdiDi>805299032TRB-IFA</basicUdiDi>
    <tradeName>FlowMIR Disposable Turbine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910001.</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:39:59.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990320219</udiDi>
    <basicUdiDi>805299032TRB-RUJ7</basicUdiDi>
    <tradeName>Nuvoair Disposable Turbine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:39:41.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142190929</udiDi>
    <basicUdiDi>764014219AccessoriesXD</basicUdiDi>
    <tradeName>EasyOne Air Cradle</tradeName>
    <deviceName>Accessories</deviceName>
    <manufacturerName>NDD Medizintechnik AG</manufacturerName>
    <manufacturerSrn>CH-MF-000015550</manufacturerSrn>
    <authorisedRepresentativeName>NDD Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000032322</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2500-50.11sp</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:14.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142190707</udiDi>
    <basicUdiDi>764014219FlowSensorRW</basicUdiDi>
    <tradeName>Easy on-PC flow sensor / Spiroson-AS</tradeName>
    <deviceName>Flow Sensor</deviceName>
    <manufacturerName>NDD Medizintechnik AG</manufacturerName>
    <manufacturerSrn>CH-MF-000015550</manufacturerSrn>
    <authorisedRepresentativeName>NDD Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000032322</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:10.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142190479</udiDi>
    <basicUdiDi>764014219SensorKitPX</basicUdiDi>
    <tradeName>Spiro-SP TrueFlow Sensor</tradeName>
    <deviceName>Flow Sensor Kit</deviceName>
    <manufacturerName>NDD Medizintechnik AG</manufacturerName>
    <manufacturerSrn>CH-MF-000015550</manufacturerSrn>
    <authorisedRepresentativeName>NDD Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000032322</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2700-1SP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:26:08.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970548490318</udiDi>
    <basicUdiDi>697054849FT1SN</basicUdiDi>
    <tradeName>06970548490318</tradeName>
    <deviceName>Valve Head</deviceName>
    <manufacturerName>Xeek (Xiamen) Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015570</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F060111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:20:03.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958066416010</udiDi>
    <basicUdiDi>69580664TB1201LF</basicUdiDi>
    <tradeName>Beneware</tradeName>
    <deviceName>Disposable turbine</deviceName>
    <manufacturerName>Suzhou Beneware Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015853</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-TB-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:12:36.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980108242</udiDi>
    <basicUdiDi>69239801ND1DANJ</basicUdiDi>
    <tradeName>Nose Clip Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142190714</udiDi>
    <basicUdiDi>764014219FlowSensorRW</basicUdiDi>
    <tradeName>Spiro-SP flow sensor / Spiroson-AS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NDD Medizintechnik AG</manufacturerName>
    <manufacturerSrn>CH-MF-000015550</manufacturerSrn>
    <authorisedRepresentativeName>NDD Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000032322</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:54:56.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142190875</udiDi>
    <basicUdiDi>764014219FlowSensorRW</basicUdiDi>
    <tradeName>EasyOne Air Spirometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NDD Medizintechnik AG</manufacturerName>
    <manufacturerSrn>CH-MF-000015550</manufacturerSrn>
    <authorisedRepresentativeName>NDD Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000032322</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:54:56.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142190905</udiDi>
    <basicUdiDi>764014219FlowSensorRW</basicUdiDi>
    <tradeName>TrueFlow Sensor FT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NDD Medizintechnik AG</manufacturerName>
    <manufacturerSrn>CH-MF-000015550</manufacturerSrn>
    <authorisedRepresentativeName>NDD Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000032322</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:54:56.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321179</udiDi>
    <basicUdiDi>805299032TRB-RUJ7</basicUdiDi>
    <tradeName>FlowMIR Disposable Turbine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:30:57.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321605</udiDi>
    <basicUdiDi>805299032TRB-IFA</basicUdiDi>
    <tradeName>Reusable Turbine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:30:57.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321834</udiDi>
    <basicUdiDi>805299032TRB-RUJ7</basicUdiDi>
    <tradeName>FlowMIR Disposable Turbine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:30:56.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052990321841</udiDi>
    <basicUdiDi>805299032TRB-RUJ7</basicUdiDi>
    <tradeName>FlowMIR Disposable Turbine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MIR - Medical International Research S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000014026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150180</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:30:56.957Z</lastUpdated>
  </row>
</eudamedExport>