<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00857522005101</udiDi>
    <basicUdiDi>08575220053000slFB</basicUdiDi>
    <tradeName>myPatch®sl</tradeName>
    <deviceName>myPatch®sl</deviceName>
    <manufacturerName>dms-service, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008977</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000sl</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:41:52.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522128851</udiDi>
    <basicUdiDi>08415221IIa98700OWNJ9</basicUdiDi>
    <tradeName>ECLIPSE PRO RECORDER,MULTILINGUAL</tradeName>
    <deviceName>Eclipse Pro</deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98700</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:16:25.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522128769</udiDi>
    <basicUdiDi>08415221IIa98900OWNK3</basicUdiDi>
    <tradeName>ECLIPSE MINI RECORDER, MULTILINGUAL</tradeName>
    <deviceName>Eclipse Mini</deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98900</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:16:21.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522125133</udiDi>
    <basicUdiDi>08415221IIaTAYOWNJJ</basicUdiDi>
    <tradeName>4 ELECTRODE EVO RECORDER PACKED</tradeName>
    <deviceName>EVO Recorder</deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>50-0034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:16:09.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811331010251</udiDi>
    <basicUdiDi>081133101H3R-0039AY</basicUdiDi>
    <tradeName>Clarus Holter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TZ Medical inc</manufacturerName>
    <manufacturerSrn>US-MF-000027311</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3R-0039</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:58:43.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290110254513</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-314</tradeName>
    <deviceName>NR Series</deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR314-D-00E-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:28.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B972CC01020B</udiDi>
    <basicUdiDi>++B972TELECC32W</basicUdiDi>
    <tradeName>TELECARDIOCALM</tradeName>
    <deviceName>TELECARDIOCALM</deviceName>
    <manufacturerName>CARDIO CALM S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000033759</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC0102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T14:18:43.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-benecareUYE</udiDi>
    <basicUdiDi>B-benecareUYE</basicUdiDi>
    <tradeName>D-benecareUYE</tradeName>
    <deviceName>Wearable Ambulatory ECG Recorder</deviceName>
    <manufacturerName>Shenzhen Benevolence Medical Sci&amp;Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021136</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:08.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-benecareMXW</udiDi>
    <basicUdiDi>B-benecareMXW</basicUdiDi>
    <tradeName>D-benecareMXW</tradeName>
    <deviceName>Ambulatory ECG Recorder</deviceName>
    <manufacturerName>Shenzhen Benevolence Medical Sci&amp;Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021136</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:08.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NOMF000013438ECG247P9</udiDi>
    <basicUdiDi>B-NOMF000013438ECG247P9</basicUdiDi>
    <tradeName>ECG247 Smart Heart Sensor</tradeName>
    <deviceName>ECG247 Smart Heart Sensor System</deviceName>
    <manufacturerName>Appsens AS</manufacturerName>
    <manufacturerSrn>NO-MF-000013438</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4000</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:23:49.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-P12/8i26</udiDi>
    <basicUdiDi>B-HeartView-P12/8i26</basicUdiDi>
    <tradeName>D-HeartView-P12/8i26</tradeName>
    <deviceName>HeartView</deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P12/8i</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:00:12.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-P12/8MobileMS</udiDi>
    <basicUdiDi>B-HeartView-P12/8MobileMS</basicUdiDi>
    <tradeName>D-HeartView-P12/8MobileMS</tradeName>
    <deviceName>HeartView</deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P12/8 Mobile</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:57.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-12iZM</udiDi>
    <basicUdiDi>B-HeartView-12iZM</basicUdiDi>
    <tradeName>D-HeartView-12iZM</tradeName>
    <deviceName>HeartView</deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12i</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:56.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-12LY5</udiDi>
    <basicUdiDi>B-HeartView-12LY5</basicUdiDi>
    <tradeName>D-HeartView-12LY5</tradeName>
    <deviceName>HeartView</deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:52.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Faros360X9</udiDi>
    <basicUdiDi>B-Faros360X9</basicUdiDi>
    <tradeName>D-Faros360X9</tradeName>
    <deviceName>Faros 360</deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9404300</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:30:22.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Faros180X5</udiDi>
    <basicUdiDi>B-Faros180X5</basicUdiDi>
    <tradeName>D-Faros180X5</tradeName>
    <deviceName>Faros 180</deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9404302</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:30:21.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Faros180L2W</udiDi>
    <basicUdiDi>B-Faros180L2W</basicUdiDi>
    <tradeName>D-Faros180L2W</tradeName>
    <deviceName>Faros 180L</deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9404659</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:30:20.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Faros14DXX</udiDi>
    <basicUdiDi>B-Faros14DXX</basicUdiDi>
    <tradeName>D-Faros14DXX</tradeName>
    <deviceName>Faros14D</deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9305243</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:30:16.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-CA01-2017-1781GJ</udiDi>
    <basicUdiDi>B-FI-CA01-2017-1781GJ</basicUdiDi>
    <tradeName>CloudHolter</tradeName>
    <deviceName>CloudHolter</deviceName>
    <manufacturerName>Oy Diagnostic Devices Development</manufacturerName>
    <manufacturerSrn>FI-MF-000017197</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>05</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:43.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117200889</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NRP-USB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORAV Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000007856</manufacturerSrn>
    <authorisedRepresentativeName>Norav Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007459</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NRP-USB-DOCKING-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:45:19.291Z</lastUpdated>
  </row>
</eudamedExport>