<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-RBH01C0000M4</udiDi>
    <basicUdiDi>B-RBH01C0000M4</basicUdiDi>
    <tradeName>Kit Consommable R-One</tradeName>
    <deviceName>R-One consumable kit</deviceName>
    <manufacturerName>ROBOCATH S.A.S</manufacturerName>
    <manufacturerSrn>FR-MF-000003651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12059085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RBH01C0000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:02.449Z</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>MEDISSUITEXA2023</udiDi>
    <basicUdiDi>B-MEDISSUITEXA2023</basicUdiDi>
    <tradeName>Medis Suite</tradeName>
    <deviceName>QAngio XA and QAngio XA 3D</deviceName>
    <manufacturerName>Medis Medical Imaging Systems bv</manufacturerName>
    <manufacturerSrn>NL-MF-000002670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050582</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20240115</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:10:49.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>MEDISSUITEMRCT2023</udiDi>
    <basicUdiDi>B-MEDISSUITEMRCT2023</basicUdiDi>
    <tradeName>Medis Suite MRCT</tradeName>
    <deviceName>Medis Suite MRCT 2023</deviceName>
    <manufacturerName>Medis Medical Imaging Systems bv</manufacturerName>
    <manufacturerSrn>NL-MF-000002670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050582</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20240115</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:10:48.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>MEDISSUITE2022</udiDi>
    <basicUdiDi>B-MEDISSUITE2022</basicUdiDi>
    <tradeName>Medis</tradeName>
    <deviceName>Medis Suite 2022</deviceName>
    <manufacturerName>Medis Medical Imaging Systems bv</manufacturerName>
    <manufacturerSrn>NL-MF-000002670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050582</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20220504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:10:47.093Z</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-HS80G-L1BE</udiDi>
    <basicUdiDi>B-HS80G-L1BE</basicUdiDi>
    <tradeName>HS80G-L1 12 channel ECG device</tradeName>
    <deviceName>HS80G-L1 12 channel ECG device</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000017747</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050302</emdnCode>
    <emdnDescription>ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHS80GL1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:49.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HS112-C13P</udiDi>
    <basicUdiDi>B-HS112-C13P</basicUdiDi>
    <tradeName>HS112-C1 12 channel ECG device</tradeName>
    <deviceName>HS112-C1 12 channel ECG device</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000017747</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050302</emdnCode>
    <emdnDescription>ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHS112C1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:49.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>G532CMD0E</udiDi>
    <basicUdiDi>B-G532CMD0E</basicUdiDi>
    <tradeName>CorEx</tradeName>
    <deviceName>CorEx</deviceName>
    <manufacturerName>Spimed-AI</manufacturerName>
    <manufacturerSrn>FR-MF-000036589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12059082</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:06:33.759Z</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>00812345025705</udiDi>
    <basicUdiDi>0732094GMN901006BNJ</basicUdiDi>
    <tradeName>WAM/AMXX Lead Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-047-71</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:26.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812345025682</udiDi>
    <basicUdiDi>0732094GMN901006BNJ</basicUdiDi>
    <tradeName>WAM/AMXX Lead Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-047-67</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:26.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812345025668</udiDi>
    <basicUdiDi>0732094GMN901006BNJ</basicUdiDi>
    <tradeName>WAM/AMXX Lead Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-047-65</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:26.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812345021998</udiDi>
    <basicUdiDi>0732094GMN901006BNJ</basicUdiDi>
    <tradeName>WAM/AMXX Lead Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-047-60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:26.687Z</lastUpdated>
  </row>
</eudamedExport>