<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800184100006</udiDi>
    <basicUdiDi>8800184SPIRO54</basicUdiDi>
    <tradeName>08800184100006</tradeName>
    <deviceName>SPIRO LENIS</deviceName>
    <manufacturerName>JNBIO</manufacturerName>
    <manufacturerSrn>KR-MF-000042575</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>PRD-LS-001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:22.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106432</udiDi>
    <basicUdiDi>69450401SP70BLZ</basicUdiDi>
    <tradeName>SPIROMETER</tradeName>
    <deviceName>SPIROMETER</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP80B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:03:44.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802604656</udiDi>
    <basicUdiDi>69268026SP0300000000001TR</basicUdiDi>
    <tradeName>06926802604656</tradeName>
    <deviceName>Spirometer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:34.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802604618</udiDi>
    <basicUdiDi>69268026SP0200000000001SL</basicUdiDi>
    <tradeName>06926802604618</tradeName>
    <deviceName>Spirometer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:34.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802604571</udiDi>
    <basicUdiDi>69268026SP0100000000001RF</basicUdiDi>
    <tradeName>06926802604571</tradeName>
    <deviceName>Spirometer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:30.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000868</udiDi>
    <basicUdiDi>6420099M9497LW</basicUdiDi>
    <tradeName>Medikro Duo</tradeName>
    <deviceName>Medikro Duo</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M920</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:37:25.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000851</udiDi>
    <basicUdiDi>6420099M9492LL</basicUdiDi>
    <tradeName>Medikro Primo</tradeName>
    <deviceName>Medikro Primo</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M914</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:37:25.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420099000837</udiDi>
    <basicUdiDi>6420099M9488LV</basicUdiDi>
    <tradeName>Medikro Pro</tradeName>
    <deviceName>Medikro Pro</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M915</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:37:18.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760253450003</udiDi>
    <basicUdiDi>376025345FF1037TL</basicUdiDi>
    <tradeName>Spirolyser Q13</tradeName>
    <deviceName>Spirolyser Q13</deviceName>
    <manufacturerName>FIM Medical</manufacturerName>
    <manufacturerSrn>FR-MF-000017090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FF1037</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:54:37.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040100355</udiDi>
    <basicUdiDi>B-06945040100355</basicUdiDi>
    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:54:33.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>111751440179</udiDi>
    <basicUdiDi>PP17514EXH70</basicUdiDi>
    <tradeName>EXHALYZER D</tradeName>
    <deviceName>EXHALYZER D</deviceName>
    <manufacturerName>ECO PHYSICS AG</manufacturerName>
    <manufacturerSrn>CH-MF-000026912</manufacturerSrn>
    <authorisedRepresentativeName>ECO PHYSICS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005287</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M3024/X3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:42:56.262Z</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>
  <row>
    <udiDi>D-M9488SV</udiDi>
    <basicUdiDi>B-M9488SV</basicUdiDi>
    <tradeName>D-M9488SV</tradeName>
    <deviceName>Medikro® Pro</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>M915</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:36.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9488-WAZ2</udiDi>
    <basicUdiDi>B-M9488-WAZ2</basicUdiDi>
    <tradeName>D-M9488-WAZ2</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>M915-WA, Ref 410027</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:35.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9488-WA2KC</udiDi>
    <basicUdiDi>B-M9488-WA2KC</basicUdiDi>
    <tradeName>D-M9488-WA2KC</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>M915-WA2, Ref 410857</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:34.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9488-EHK</udiDi>
    <basicUdiDi>B-M9488-EHK</basicUdiDi>
    <tradeName>D-M9488-EHK</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>M915-E</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:34.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0860000692809RU</udiDi>
    <basicUdiDi>B-0860000692809RU</basicUdiDi>
    <tradeName>GoSpiro</tradeName>
    <deviceName>GoSpiro</deviceName>
    <manufacturerName>MedChip Solutions Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000018689</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GoSpiro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:03:32.138Z</lastUpdated>
  </row>
</eudamedExport>