<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05905178315510</udiDi>
    <basicUdiDi>59051783155SHENAI_MD4P</basicUdiDi>
    <tradeName>Shen.AI</tradeName>
    <deviceName>Shen.AI</deviceName>
    <manufacturerName>Shen.AI OÜ</manufacturerName>
    <manufacturerSrn>EE-MF-000050105</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHENAI_MD</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:00:17.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262410360006</udiDi>
    <basicUdiDi>426241036SMTSW500X4</basicUdiDi>
    <tradeName>MIVONA KRS-MANAGER</tradeName>
    <deviceName>MIVONA KRS-MANAGER</deviceName>
    <manufacturerName>SMT Service-Medizin-Technik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMTHW500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:31:42.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262404180009</udiDi>
    <basicUdiDi>426240418ME</basicUdiDi>
    <tradeName>Noah Labs Ark</tradeName>
    <deviceName>Noah Labs Telemonitoring</deviceName>
    <manufacturerName>Noah Labs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000030840</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.x.x</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:31:28.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260686513102</udiDi>
    <basicUdiDi>426068651300AZ</basicUdiDi>
    <tradeName>NEXUS / PDMS</tradeName>
    <deviceName>NEXUS / PDMS</deviceName>
    <manufacturerName>NEXUS / CMC GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26.2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:13:14.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260497022053</udiDi>
    <basicUdiDi>426049702_NA-/NEO-Soft_H3</basicUdiDi>
    <tradeName>Narcotrend Software</tradeName>
    <deviceName>Narcotrend/Braintrend Software</deviceName>
    <manufacturerName>MT MonitorTechnik GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005317</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NM-0141</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:02:36.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413409259</udiDi>
    <basicUdiDi>42504134SoftwareHW</basicUdiDi>
    <tradeName>NightScore Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAS001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:43.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405718</udiDi>
    <basicUdiDi>42504134SoftwareHW</basicUdiDi>
    <tradeName>DOMINO Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSC090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:31:58.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405657</udiDi>
    <basicUdiDi>42504134SWABPG4</basicUdiDi>
    <tradeName>ABPMpro Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:31:56.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099966000229</udiDi>
    <basicUdiDi>4099966COACH32</basicUdiDi>
    <tradeName>Preventicus Coach / Preventicus 360°</tradeName>
    <deviceName>Preventicus Coach</deviceName>
    <manufacturerName>Preventicus GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COACH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:35:27.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060933740003</udiDi>
    <basicUdiDi>0506093374THEMIS3M</basicUdiDi>
    <tradeName>THEMIS</tradeName>
    <deviceName>THEMIS</deviceName>
    <manufacturerName>Medical Support Offshore Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019458</manufacturerSrn>
    <authorisedRepresentativeName>Medical Support Offshore BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000015699</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THEMIS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:48:18.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852132007286</udiDi>
    <basicUdiDi>B-00852132007286</basicUdiDi>
    <tradeName>PatientCare Platform</tradeName>
    <deviceName>PatientCare Platform</deviceName>
    <manufacturerName>Boston Scientific Cardiac Diagnostic Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015689</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T06:21:08.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852132007309</udiDi>
    <basicUdiDi>B-00852132007309</basicUdiDi>
    <tradeName>ECG Plug-In</tradeName>
    <deviceName>ECG Plug-In</deviceName>
    <manufacturerName>Boston Scientific Cardiac Diagnostic Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015689</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW1003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:34:39.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838094253</udiDi>
    <basicUdiDi>0884838BM539TE</basicUdiDi>
    <tradeName>IntelliVue GuardianSoftware</tradeName>
    <deviceName>IGS</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>866009</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:21:32.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851725007375</udiDi>
    <basicUdiDi>0851725007NKS-0014T</basicUdiDi>
    <tradeName>00851725007375</tradeName>
    <deviceName>NetKonnect Surveillance</deviceName>
    <manufacturerName>Nihon Kohden Digital Health Solutions LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042132</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:35:08.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>PP 13374 SLEEP 78 APNEA1.0.0</udiDi>
    <basicUdiDi>PP13374SLEEP78</basicUdiDi>
    <tradeName>DormiApnea</tradeName>
    <deviceName>DormiApnea</deviceName>
    <manufacturerName>Sleepacta Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041068</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111914608371-1.0.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:44:58.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ES-MF-00001804644</udiDi>
    <basicUdiDi>B-ES-MF-00001804644</basicUdiDi>
    <tradeName>PICASSO SOFTWARE</tradeName>
    <deviceName>CATHMED PICASSO</deviceName>
    <manufacturerName>CATHMEDICAL CARDIOVASCULAR, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000018046</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PICASSO 340-500-006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T17:52:11.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AIZOI-CLOUDQW</udiDi>
    <basicUdiDi>B-AIZOI-CLOUDQW</basicUdiDi>
    <tradeName>D-AIZOI-CLOUDQW</tradeName>
    <deviceName>PIATTAFORMA AIZOI</deviceName>
    <manufacturerName>Aizoi s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000026605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIZOI-CLOUD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:06.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299815001</udiDi>
    <basicUdiDi>B-08720299815001</basicUdiDi>
    <tradeName>Cardiovascular Monitoring Application Software</tradeName>
    <deviceName>Heart Rhythm SDK</deviceName>
    <manufacturerName>Happitech</manufacturerName>
    <manufacturerSrn>NL-MF-000023900</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDK01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:15:54.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>04053815080800</udiDi>
    <basicUdiDi>B-04053815080800</basicUdiDi>
    <tradeName>ECG Top D</tradeName>
    <deviceName>ECG Top D</deviceName>
    <manufacturerName>Zimmer MedizinSysteme GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006141</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1736</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:23:30.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850010298030</udiDi>
    <basicUdiDi>B-00850010298030</basicUdiDi>
    <tradeName>00850010298030</tradeName>
    <deviceName>Eko Analysis Software</deviceName>
    <manufacturerName>Eko Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034386</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EAS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:56:03.546Z</lastUpdated>
  </row>
</eudamedExport>