<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06958066408121</udiDi>
    <basicUdiDi>B-06958066408121</basicUdiDi>
    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer systems</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-13-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:12:07.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958066408114</udiDi>
    <basicUdiDi>B-06958066408114</basicUdiDi>
    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer systems</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-12-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:12:06.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958066408107</udiDi>
    <basicUdiDi>B-06958066408107</basicUdiDi>
    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer systems</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-11-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:12:05.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958066408091</udiDi>
    <basicUdiDi>B-06958066408091</basicUdiDi>
    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer systems</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-03-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:11:59.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958066408084</udiDi>
    <basicUdiDi>B-06958066408084</basicUdiDi>
    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer systems</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-02-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:11:57.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958066408077</udiDi>
    <basicUdiDi>B-06958066408077</basicUdiDi>
    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer systems</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-01-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:11:56.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>08903545020149</udiDi>
    <basicUdiDi>8903545GMLREX033N5</basicUdiDi>
    <tradeName>Mediciser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Global Medikit Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013635</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6040011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T05:41:07.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>04745010564222</udiDi>
    <basicUdiDi>474501056410010B3</basicUdiDi>
    <tradeName>04745010564222</tradeName>
    <deviceName></deviceName>
    <manufacturerName>1M4 OÜ</manufacturerName>
    <manufacturerSrn>EE-MF-000040367</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10020.00</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:47.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000301</udiDi>
    <basicUdiDi>6420099M9264L5</basicUdiDi>
    <tradeName>06420099000301</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9274-WA, ref 410370</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:58.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000370</udiDi>
    <basicUdiDi>6420099M9474LJ</basicUdiDi>
    <tradeName>Medikro Calibration Syringe Outlet Port Adapter Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M91175</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:58.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000387</udiDi>
    <basicUdiDi>6420099M9474LJ</basicUdiDi>
    <tradeName>Medikro Calibration Syringe, volume 3000 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9474</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:58.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000424</udiDi>
    <basicUdiDi>6420099M9474LJ</basicUdiDi>
    <tradeName>06420099000424</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9474-C</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000455</udiDi>
    <basicUdiDi>6420099M9253KY</basicUdiDi>
    <tradeName>06420099000455</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9253-200</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000462</udiDi>
    <basicUdiDi>6420099M9253KY</basicUdiDi>
    <tradeName>06420099000462</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9253-B-200</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000486</udiDi>
    <basicUdiDi>6420099M9264L5</basicUdiDi>
    <tradeName>Medikro Pressure Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9264-200</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000561</udiDi>
    <basicUdiDi>6420099M9256L6</basicUdiDi>
    <tradeName>SpiroSafe Disposable Flow Transducers</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9256-SP-90</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000684</udiDi>
    <basicUdiDi>6420099M9264L5</basicUdiDi>
    <tradeName>Pressure Tube with Grip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9274</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000912</udiDi>
    <basicUdiDi>6420099M9474LJ</basicUdiDi>
    <tradeName>06420099000912</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9278-B</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000936</udiDi>
    <basicUdiDi>6420099M9474LJ</basicUdiDi>
    <tradeName>06420099000936</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9474-B</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:57.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000974</udiDi>
    <basicUdiDi>6420099M9474LJ</basicUdiDi>
    <tradeName>06420099000974</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9474-D</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:54.761Z</lastUpdated>
  </row>
</eudamedExport>