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    <tradeName>CardioLight+</tradeName>
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    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <reference>05190100013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:11:50.243Z</lastUpdated>
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    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
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    <udiDi>00051940000346</udiDi>
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    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <udiDi>00051940000384</udiDi>
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    <tradeName>CardioSmart CS550 FR</tradeName>
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    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>CARDIOVASCULAR HOLTER ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05194000038</reference>
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    <lastUpdated>2026-06-28T19:11:50.157Z</lastUpdated>
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    <udiDi>00051950000138</udiDi>
    <basicUdiDi>78989943936CardioLight+3T</basicUdiDi>
    <tradeName>Patient Cable CL 4 Leads</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05195000013</reference>
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    <lastUpdated>2026-06-28T19:11:50.129Z</lastUpdated>
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    <udiDi>06944414031370</udiDi>
    <basicUdiDi>B-06944414031370</basicUdiDi>
    <tradeName>ECG Recorder</tradeName>
    <deviceName>心电记录仪</deviceName>
    <manufacturerName>Shenzhen Med-link Electronics Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011145</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>ECG01010102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T10:01:06.629Z</lastUpdated>
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    <udiDi>06944413831889</udiDi>
    <basicUdiDi>69444138SE3012SFV</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSE-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:08.894Z</lastUpdated>
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    <udiDi>06944413831834</udiDi>
    <basicUdiDi>69444138SE3012SFV</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:33:07.260Z</lastUpdated>
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    <udiDi>06944413820500</udiDi>
    <basicUdiDi>69444138SA20SNM</basicUdiDi>
    <tradeName>Holter ECG and ABP system</tradeName>
    <deviceName>Holter ECG and ABP  system</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050402</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:21:46.165Z</lastUpdated>
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    <udiDi>06944413820494</udiDi>
    <basicUdiDi>69444138SA20SNM</basicUdiDi>
    <tradeName>Holter ECG and ABP system</tradeName>
    <deviceName>Holter ECG and ABP  system</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050402</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:21:45.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413820487</udiDi>
    <basicUdiDi>69444138SA20SNM</basicUdiDi>
    <tradeName>Holter ECG and ABP system</tradeName>
    <deviceName>Holter ECG and ABP  system</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050402</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:21:43.752Z</lastUpdated>
  </row>
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    <udiDi>06944413820470</udiDi>
    <basicUdiDi>69444138SA20SNM</basicUdiDi>
    <tradeName>Holter ECG and ABP system</tradeName>
    <deviceName>Holter ECG and ABP  system</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050402</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:21:42.789Z</lastUpdated>
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    <udiDi>06944413820463</udiDi>
    <basicUdiDi>69444138SA20SNM</basicUdiDi>
    <tradeName>Holter ECG and ABP system</tradeName>
    <deviceName>Holter ECG and ABP  system</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050402</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:21:41.259Z</lastUpdated>
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    <udiDi>06944413812611</udiDi>
    <basicUdiDi>69444138SAS4S</basicUdiDi>
    <tradeName>Ambulatory Blood Pressure Monitor</tradeName>
    <deviceName>Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:12:05.675Z</lastUpdated>
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    <udiDi>06944413812604</udiDi>
    <basicUdiDi>69444138SAS4S</basicUdiDi>
    <tradeName>Ambulatory Blood Pressure Monitor</tradeName>
    <deviceName>Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:11:59.545Z</lastUpdated>
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    <udiDi>06944413812598</udiDi>
    <basicUdiDi>69444138SAS4S</basicUdiDi>
    <tradeName>Ambulatory Blood Pressure Monitor</tradeName>
    <deviceName>Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:11:58.127Z</lastUpdated>
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    <udiDi>06944413812581</udiDi>
    <basicUdiDi>69444138SAS4S</basicUdiDi>
    <tradeName>Ambulatory Blood Pressure Monitor</tradeName>
    <deviceName>Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:11:57.231Z</lastUpdated>
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    <udiDi>06944413812574</udiDi>
    <basicUdiDi>69444138SAS4S</basicUdiDi>
    <tradeName>Ambulatory Blood Pressure Monitor</tradeName>
    <deviceName>Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:11:56.369Z</lastUpdated>
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    <udiDi>06944413807679</udiDi>
    <basicUdiDi>69444138SE2003SFG</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-2003A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:06:12.723Z</lastUpdated>
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    <udiDi>06944413807686</udiDi>
    <basicUdiDi>69444138SE2003SFG</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-2012A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:06:06.418Z</lastUpdated>
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