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<eudamedExport entity="devices">
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    <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>
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  <row>
    <udiDi>00812345022711</udiDi>
    <basicUdiDi>0732094GMN901006ENQ</basicUdiDi>
    <tradeName>H12+ Patient Cable</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>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-017-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:00:43.672Z</lastUpdated>
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    <udiDi>B972CCZ12050482050</udiDi>
    <basicUdiDi>++B972CERS437</basicUdiDi>
    <tradeName>CER-S</tradeName>
    <deviceName>CER-S</deviceName>
    <manufacturerName>CARDIO CALM S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000017950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050482</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCZ1205048205</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T14:23:20.887Z</lastUpdated>
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    <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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    <udiDi>00812345022728</udiDi>
    <basicUdiDi>0732094GMN901006ENQ</basicUdiDi>
    <tradeName>H12+ Patient Cable</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>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-026-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:10.675Z</lastUpdated>
  </row>
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    <udiDi>00812345024883</udiDi>
    <basicUdiDi>0732094GMN901006ENQ</basicUdiDi>
    <tradeName>H12+ Patient Cable</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>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-026-51</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:09.849Z</lastUpdated>
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    <udiDi>00812345024807</udiDi>
    <basicUdiDi>0732094GMN901006ENQ</basicUdiDi>
    <tradeName>H12+ Patient Cable</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>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-017-51</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:09.671Z</lastUpdated>
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    <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>
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    <udiDi>04250903200267</udiDi>
    <basicUdiDi>0425090320234N7</basicUdiDi>
    <tradeName>CM 3000 GETEMED AMB-EKG-PAT-CABLE SWITCH DIG 7P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2014606-044 / 90249</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:28:18.357Z</lastUpdated>
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