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<eudamedExport entity="devices">
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    <tradeName>ECG247 Software Solution</tradeName>
    <deviceName>ECG247 Smart Sensor Software Solution</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>005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:22.311Z</lastUpdated>
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  <row>
    <udiDi>D-7090052220030SH</udiDi>
    <basicUdiDi>B-7090052220030SH</basicUdiDi>
    <tradeName>ECG247 Smart Sensor APP</tradeName>
    <deviceName>ECG247 APP to be used with ECG247 Smart Sensor</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>003</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:21.588Z</lastUpdated>
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  <row>
    <udiDi>D-7090052220009SS</udiDi>
    <basicUdiDi>B-7090052220009SS</basicUdiDi>
    <tradeName>ECG247 Smart Sensor and Electrode</tradeName>
    <deviceName>ECG247 Smart Sensor and Electrode</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>001</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:17.167Z</lastUpdated>
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    <udiDi>D-7022750045035SS</udiDi>
    <basicUdiDi>B-7022750045035SS</basicUdiDi>
    <tradeName>ECG247 Electrode patch</tradeName>
    <deviceName>ECG247 Electrode Patch</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>2</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:04.737Z</lastUpdated>
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  <row>
    <udiDi>D-7022750045004SF</udiDi>
    <basicUdiDi>B-7022750045004SF</basicUdiDi>
    <tradeName>ECG247 Smart Sensor</tradeName>
    <deviceName>ECG247 Smart Sensor</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>002</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:01.148Z</lastUpdated>
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  <row>
    <udiDi>59044737177464</udiDi>
    <basicUdiDi>B-59044737177464</basicUdiDi>
    <tradeName>EM-01</tradeName>
    <deviceName>EM-01 - wireless ECG module</deviceName>
    <manufacturerName>EMTEL Śliwa spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000006848</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:01:12.647Z</lastUpdated>
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  <row>
    <udiDi>D-50002_a3A</udiDi>
    <basicUdiDi>B-50002_a3A</basicUdiDi>
    <tradeName>Cortrium Apex</tradeName>
    <deviceName>Cortrium Apex</deviceName>
    <manufacturerName>Cortrium ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000007827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50002_a</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:29.437Z</lastUpdated>
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  <row>
    <udiDi>D-50002F9</udiDi>
    <basicUdiDi>B-50002F9</basicUdiDi>
    <tradeName>C3+ Holter Monitor</tradeName>
    <deviceName>C3+ Holter Monitor</deviceName>
    <manufacturerName>Cortrium ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000007827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50002</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:29.085Z</lastUpdated>
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  <row>
    <udiDi>04037691108841</udiDi>
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    <tradeName>HKH 7900 Holder for PLS-i oxygenator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maquet Cardiopulmonary GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701031554</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:28:16.851Z</lastUpdated>
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    <udiDi>04037691533339</udiDi>
    <basicUdiDi>405886357664FE</basicUdiDi>
    <tradeName>HKHZ 19 Single holder oxygenat. neo/ped</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maquet Cardiopulmonary GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701047495</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:28:16.648Z</lastUpdated>
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    <udiDi>04037691576640</udiDi>
    <basicUdiDi>405886357664FE</basicUdiDi>
    <tradeName>016061 Holder arm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maquet Cardiopulmonary GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701048947</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:28:16.538Z</lastUpdated>
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    <udiDi>04037691588285</udiDi>
    <basicUdiDi>405886357664FE</basicUdiDi>
    <tradeName>HKH 8870 Holder for priming bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maquet Cardiopulmonary GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701049375</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:28:16.251Z</lastUpdated>
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  <row>
    <udiDi>04037691753430</udiDi>
    <basicUdiDi>405886357664FE</basicUdiDi>
    <tradeName>HKHZ 27 Adapter for oxygenator neo/ped</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maquet Cardiopulmonary GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701053567</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:28:15.416Z</lastUpdated>
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  <row>
    <udiDi>06947772300164</udiDi>
    <basicUdiDi>B-06947772300164</basicUdiDi>
    <tradeName>ECG recording paper</tradeName>
    <deviceName>ECG recording paper</deviceName>
    <manufacturerName>TIANJIN GRAND PAPER INDUSTRY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000039618</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050685</emdnCode>
    <emdnDescription>NON-IMPLANTABLE CARDIAC STIMULATORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES-AR-000001202</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:35.421Z</lastUpdated>
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    <udiDi>06945040100478</udiDi>
    <basicUdiDi>B-06945040100478</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG300GT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:54:38.540Z</lastUpdated>
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    <udiDi>06945040100072</udiDi>
    <basicUdiDi>B-06945040100072</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG100G</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:54:11.282Z</lastUpdated>
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    <udiDi>05999883490525</udiDi>
    <basicUdiDi>B-05999883490525</basicUdiDi>
    <tradeName>EC-ABP</tradeName>
    <deviceName>EC-ABP Long Term Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-00ABP-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:53.977Z</lastUpdated>
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    <udiDi>05999883490235</udiDi>
    <basicUdiDi>B-05999883490235</basicUdiDi>
    <tradeName>EC-12RM</tradeName>
    <deviceName>EC-12RM 12-channel mobile and emergency ECG</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-012RM-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:53.301Z</lastUpdated>
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    <udiDi>05999883490228</udiDi>
    <basicUdiDi>B-05999883490228</basicUdiDi>
    <tradeName>EC-12S</tradeName>
    <deviceName>EC-12S 12-channel Stress ECG with Blood Pressure Monitor</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-0012S-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:52.385Z</lastUpdated>
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    <udiDi>05999883490211</udiDi>
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    <tradeName>EC-12R/S</tradeName>
    <deviceName>EC-12R/S PC-based 12-channel resting and stress ECG</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-012RS-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:51.581Z</lastUpdated>
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</eudamedExport>