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    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <reference>EC-ABP V6 Recorder</reference>
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    <lastUpdated>2026-07-06T03:18:22.926Z</lastUpdated>
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    <deviceName></deviceName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <reference>EC-3H/ABP V6 Recorder</reference>
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    <deviceName></deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <reference>EC-12H/ABP V6 Recorder</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.873Z</lastUpdated>
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    <udiDi>05999883490501</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-2H System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-2H System</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.686Z</lastUpdated>
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    <udiDi>05999883490518</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-3H System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-3H System</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.660Z</lastUpdated>
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    <udiDi>05999883490549</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-12H System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-12H System</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.594Z</lastUpdated>
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    <udiDi>05999883490556</udiDi>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-ABP V6 System</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.554Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-3H/ABP V6 System</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.521Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-12H/ABP V6 System</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.496Z</lastUpdated>
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    <udiDi>06945040101406</udiDi>
    <basicUdiDi>69450401TLC6000GX</basicUdiDi>
    <tradeName>Dynamic ECG Systems</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLC6000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:58.267Z</lastUpdated>
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    <udiDi>07290117200384</udiDi>
    <basicUdiDi>0729011720NM2069202AMBAN</basicUdiDi>
    <tradeName>NR-302</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>NR302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:46:13.655Z</lastUpdated>
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    <udiDi>00884838000476</udiDi>
    <basicUdiDi>B-00884838000476</basicUdiDi>
    <tradeName>DigiTrak XT Holter Recorder</tradeName>
    <deviceName>DigiTrak XT Recorder</deviceName>
    <manufacturerName>Philips Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000002321</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860322</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:00:04.675Z</lastUpdated>
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    <udiDi>00840682108201</udiDi>
    <basicUdiDi>B-00840682108201</basicUdiDi>
    <tradeName>SEER 12</tradeName>
    <deviceName>SEER 12</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80175-EU1Set, 80175-EU2Set, 80175-EU3Set, 80175-EU4Set, 80175-EU5Set</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:38:26.147Z</lastUpdated>
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    <basicUdiDi>87202997353SenseLinkDC</basicUdiDi>
    <tradeName>08720299735309</tradeName>
    <deviceName>SenseLink</deviceName>
    <manufacturerName>TeMeCo B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011503</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SL01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:49:39.815Z</lastUpdated>
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    <tradeName>SMART ECG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MicroPort CRM S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000029013</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K379</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:44:15.842Z</lastUpdated>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
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    <reference>RC013</reference>
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    <lastUpdated>2026-07-03T04:44:11.823Z</lastUpdated>
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    <tradeName>CardioLight+</tradeName>
    <deviceName>Cardios Digital Holter Recorder</deviceName>
    <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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    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05190100011</reference>
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    <lastUpdated>2026-07-03T04:08:34.497Z</lastUpdated>
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    <tradeName>medilogFD</tradeName>
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    <manufacturerName>SCHILLER AG</manufacturerName>
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    <authorisedRepresentativeName>SCHILLER Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006934</authorisedRepresentativeSrn>
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    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.900491</reference>
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    <lastUpdated>2026-07-03T03:03:59.439Z</lastUpdated>
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    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.920740</reference>
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    <lastUpdated>2026-07-03T03:03:44.210Z</lastUpdated>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:15:35.474Z</lastUpdated>
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