<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>G159S1BB09800</udiDi>
    <basicUdiDi>B-G159S1BB09800</basicUdiDi>
    <tradeName>Saver One S1</tradeName>
    <deviceName>External Cardiac Defibrillator</deviceName>
    <manufacturerName>A.M.I. Italia s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000016770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1B-B0980</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:47:14.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>G159S1BB09810</udiDi>
    <basicUdiDi>B-G159S1BB09810</basicUdiDi>
    <tradeName>Saver One S1</tradeName>
    <deviceName>External Cardiac Defibrillator</deviceName>
    <manufacturerName>A.M.I. Italia s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000016770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1B-B0981</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:47:13.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-1AEDPlusHV</udiDi>
    <basicUdiDi>B-CA-1AEDPlusHV</basicUdiDi>
    <tradeName>CA-1 AED Plus Automated External Defibrillator</tradeName>
    <deviceName>CA-1 AED Plus Automated Defibrillator</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000017747</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCA1P</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:28.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-1AEDEH</udiDi>
    <basicUdiDi>B-CA-1AEDEH</basicUdiDi>
    <tradeName>CA-1 AED Semi-automatic defibrillator</tradeName>
    <deviceName>CA-1 AED Semi-automatic Defibrillator</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000017747</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCA1B</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:27.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-74018HA</udiDi>
    <basicUdiDi>B-74018HA</basicUdiDi>
    <tradeName>PRIMEDIC battery</tradeName>
    <deviceName>PRIMEDIC Battery 6</deviceName>
    <manufacturerName>Metrax GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005478</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97641</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:42.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-74017H8</udiDi>
    <basicUdiDi>B-74017H8</basicUdiDi>
    <tradeName>PRIMEDIC battery</tradeName>
    <deviceName>PRIMEDIC Battery 3</deviceName>
    <manufacturerName>Metrax GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005478</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97640</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:41.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908019743043</udiDi>
    <basicUdiDi>B-08908019743043</basicUdiDi>
    <tradeName>DEFIGARD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Schiller Healthcare India Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000048425</manufacturerSrn>
    <authorisedRepresentativeName>SCHILLER MEDICAL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000021375</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:07.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908019743005</udiDi>
    <basicUdiDi>B-08908019743005</basicUdiDi>
    <tradeName>DEFIGARD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Schiller Healthcare India Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000048425</manufacturerSrn>
    <authorisedRepresentativeName>SCHILLER MEDICAL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000021375</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:06.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809435482021</udiDi>
    <basicUdiDi>B-08809435482021</basicUdiDi>
    <tradeName>i-PAD</tradeName>
    <deviceName>Defibrillator</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSO-I-004-R1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:07:01.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809435482014</udiDi>
    <basicUdiDi>B-08809435482014</basicUdiDi>
    <tradeName>i-PAD</tradeName>
    <deviceName>Defibrillator</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CSO-I-004-R1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:59.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809435481161</udiDi>
    <basicUdiDi>B-08809435481161</basicUdiDi>
    <tradeName>i-PAD</tradeName>
    <deviceName>Defibrillator</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSO-I-004-R1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:56.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809435481000</udiDi>
    <basicUdiDi>B-08809435481000</basicUdiDi>
    <tradeName>i-PAD</tradeName>
    <deviceName>Defibrillator</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSO-I-004-R1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:49.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809435480461</udiDi>
    <basicUdiDi>B-08809435480461</basicUdiDi>
    <tradeName>i-PAD</tradeName>
    <deviceName>Defibrillator</deviceName>
    <manufacturerName>CU Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000018333</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSO-I-004-R1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:06:45.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009900224</udiDi>
    <basicUdiDi>B-08800009900224</basicUdiDi>
    <tradeName>Heart+ResQ</tradeName>
    <deviceName>Heart+ResQ (HeartPlusResQ)</deviceName>
    <manufacturerName>Nanoomtech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013628</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN0114-5_1912-REV01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:51.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009900217</udiDi>
    <basicUdiDi>B-08800009900217</basicUdiDi>
    <tradeName>Heart+ResQ</tradeName>
    <deviceName>Heart+ResQ (HeartPlusResQ)</deviceName>
    <manufacturerName>Nanoomtech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013628</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN0114-5_1912-REV01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:51.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800009900200</udiDi>
    <basicUdiDi>B-08800009900200</basicUdiDi>
    <tradeName>HeartPlus</tradeName>
    <deviceName>HeartPlus (HeartPlus)</deviceName>
    <manufacturerName>Nanoomtech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013628</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN0114-1_1912</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:50.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717931766036</udiDi>
    <basicUdiDi>B-08717931766036</basicUdiDi>
    <tradeName>CardiAid®</tradeName>
    <deviceName>CardiAid® Semi-Automatic External Defibrillator</deviceName>
    <manufacturerName>Cardia International A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000002223</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F/BRO/02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:46:46.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680992312781</udiDi>
    <basicUdiDi>B-08680992312781</basicUdiDi>
    <tradeName>Defibrillator Monitor</tradeName>
    <deviceName>Defibrillator Monitor</deviceName>
    <manufacturerName>OKUMAN MEDIKAL SISTEMLER ANONIM SIRKETI</manufacturerName>
    <manufacturerSrn>TR-MF-000015167</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DFM 800</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T09:31:06.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680992312774</udiDi>
    <basicUdiDi>B-08680992312774</basicUdiDi>
    <tradeName>Defibrillator Monitor</tradeName>
    <deviceName>Defibrillator Monitor</deviceName>
    <manufacturerName>OKUMAN MEDIKAL SISTEMLER ANONIM SIRKETI</manufacturerName>
    <manufacturerSrn>TR-MF-000015167</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DFM 800</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T09:31:05.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680992312767</udiDi>
    <basicUdiDi>B-08680992312767</basicUdiDi>
    <tradeName>Defibrillator Monitor</tradeName>
    <deviceName>Defibrillator Monitor</deviceName>
    <manufacturerName>OKUMAN MEDIKAL SISTEMLER ANONIM SIRKETI</manufacturerName>
    <manufacturerSrn>TR-MF-000015167</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030501</emdnCode>
    <emdnDescription>SEMI-AUTOMATIC DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DFM 800</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T09:31:04.678Z</lastUpdated>
  </row>
</eudamedExport>