<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08595614130813</udiDi>
    <basicUdiDi>B-08595614130813</basicUdiDi>
    <tradeName>BM-03 Nanny</tradeName>
    <deviceName>BM-03 Baby breathing monitor</deviceName>
    <manufacturerName>JABLOTRON a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000033469</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-03</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:33.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594052530056</udiDi>
    <basicUdiDi>B-08594052530056</basicUdiDi>
    <tradeName>BM-02 Nanny</tradeName>
    <deviceName>BM-02 Baby breathing monitor</deviceName>
    <manufacturerName>JABLOTRON a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000033469</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-02</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:46:00.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290119471249</udiDi>
    <basicUdiDi>B-07290119471249</basicUdiDi>
    <tradeName>Babysense</tradeName>
    <deviceName>Babysense 8</deviceName>
    <manufacturerName>Hisense Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU-100/2-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:53:39.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290004018627</udiDi>
    <basicUdiDi>B-07290004018627</basicUdiDi>
    <tradeName>Babysense</tradeName>
    <deviceName>Babysense 7</deviceName>
    <manufacturerName>Hisense Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000034666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU-100/2-E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:31.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809933330015</udiDi>
    <basicUdiDi>880993333ApnoTrackEUP5</basicUdiDi>
    <tradeName>08809933330015</tradeName>
    <deviceName>Sleep Breath Monitoring Software</deviceName>
    <manufacturerName>Asleep Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000054415</manufacturerSrn>
    <authorisedRepresentativeName>SOAR &amp; PARTNERS Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000040956</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Apnotrack</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:05:36.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048533299</udiDi>
    <basicUdiDi>843404825APNEAIIBVN</basicUdiDi>
    <tradeName>Set Monitorización Brizzy 10P</tradeName>
    <deviceName>Agrupaciones Apnea IIb</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:37:17.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048345588</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Monitorización BRIZZY+10</tradeName>
    <deviceName>Agrupaciones Apnea</deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:36:58.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048476763</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Monitorización BRIZZY pk10c</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS010+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048485826</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Monitorización Brizzy+10 SCR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS010SCR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048504749</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Monitorización Brizzy NJ Pk10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS010NJ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048511419</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Kit Inicio Avance Mandibular</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG25-1009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:11.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048535088</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Inicio Apneaguard S/C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-100X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:10.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08434048560103</udiDi>
    <basicUdiDi>843404825APNEAAA</basicUdiDi>
    <tradeName>Set Monitorización BRIZZY PK10_</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIM, S.A.</manufacturerName>
    <manufacturerSrn>ES-PR-000004648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080406</emdnCode>
    <emdnDescription>APNOEA MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS010_</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:52:09.430Z</lastUpdated>
  </row>
</eudamedExport>