<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TB-932502M</udiDi>
    <basicUdiDi>B-TB-932502M</basicUdiDi>
    <tradeName>D-TB-932502M</tradeName>
    <deviceName>Volumetric Incentive Spirometer 2500ml</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>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-93250</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:48.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB-93100ZW</udiDi>
    <basicUdiDi>B-TB-93100ZW</basicUdiDi>
    <tradeName>D-TB-93100ZW</tradeName>
    <deviceName>Incentive Spirometer (Flow rate)</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>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-93100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:48.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254802</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871.21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:42.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254864</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871.22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:42.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254826</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871.23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:41.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254840</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871.24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:41.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254901</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871.25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:41.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254888</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871.26</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:40.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254741</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>NB200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:38.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254949</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>NEB 250</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>p957300-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:16.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229254963</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>NEB 650</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>p957500-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:15.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942820422355</udiDi>
    <basicUdiDi>69428204OXCTWS</basicUdiDi>
    <tradeName>Oxygen concentrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Choice Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005776</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCB-5R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:56.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PF-29200YQ</udiDi>
    <basicUdiDi>B-PF-29200YQ</basicUdiDi>
    <tradeName>D-PF-29200YQ</tradeName>
    <deviceName>Peak flow meter – Low range 50-300 L/min</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-29200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:43:00.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PF-29100YK</udiDi>
    <basicUdiDi>B-PF-29100YK</basicUdiDi>
    <tradeName>D-PF-29100YK</tradeName>
    <deviceName>Peak flow meter - Standard range 50-800 L/min</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-29100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:42:59.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OC7Z</udiDi>
    <basicUdiDi>B-OC7Z</basicUdiDi>
    <tradeName>D-OC7Z</tradeName>
    <deviceName>OXYGEN CONCENTRATOR</deviceName>
    <manufacturerName>ELMASLAR İMALAT TIBBİ CİHAZLAR İNŞ. TAŞ.İTH.İHR.SAN. VE TİC.A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000030191</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT03</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:10.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9831SL</udiDi>
    <basicUdiDi>B-M9831SL</basicUdiDi>
    <tradeName>D-M9831SL</tradeName>
    <deviceName>Medikro® Spirometry Software</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150192</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9831</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:46.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9497SW</udiDi>
    <basicUdiDi>B-M9497SW</basicUdiDi>
    <tradeName>D-M9497SW</tradeName>
    <deviceName>Medikro® Duo</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M920</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:42.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9497-EHM</udiDi>
    <basicUdiDi>B-M9497-EHM</basicUdiDi>
    <tradeName>D-M9497-EHM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M920-E</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:42.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9492SL</udiDi>
    <basicUdiDi>B-M9492SL</basicUdiDi>
    <tradeName>D-M9492SL</tradeName>
    <deviceName>Medikro® Primo</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M914</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:41.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9492-EGU</udiDi>
    <basicUdiDi>B-M9492-EGU</basicUdiDi>
    <tradeName>D-M9492-EGU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M914-E</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:40.674Z</lastUpdated>
  </row>
</eudamedExport>