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    <tradeName>Fetal Telemetry System</tradeName>
    <deviceName>Fetal Telemetry System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTS-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:42.218Z</lastUpdated>
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    <udiDi>04041346101217</udiDi>
    <basicUdiDi>40413461009536</basicUdiDi>
    <tradeName>Tel-O-Graph® Manschette M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IEM GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>04041346101217</reference>
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    <udiDi>04041346101224</udiDi>
    <basicUdiDi>40413461009536</basicUdiDi>
    <tradeName>Tel-O-Graph® Manschette L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IEM GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020685</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04041346101224</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>04041346101231</udiDi>
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    <tradeName>Tel-O-Graph® Manschette XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IEM GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020685</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04041346101231</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:39:22.221Z</lastUpdated>
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    <udiDi>05905331580373</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580373</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:59.779Z</lastUpdated>
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    <udiDi>05905331580366</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580366</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:58.584Z</lastUpdated>
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    <udiDi>05905331580311</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580311</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:57.367Z</lastUpdated>
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    <udiDi>05905331580298</udiDi>
    <basicUdiDi>590533158HH2.17YF</basicUdiDi>
    <tradeName>Comarch HomeHealth 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580298</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:54.981Z</lastUpdated>
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    <udiDi>05905331580281</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580281</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:53.826Z</lastUpdated>
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    <udiDi>05905331580274</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580274</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:52.573Z</lastUpdated>
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    <udiDi>05905331580267</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580267</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:51.369Z</lastUpdated>
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    <udiDi>05905331580250</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580250</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:50.169Z</lastUpdated>
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    <udiDi>05905331580236</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580236</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:47.769Z</lastUpdated>
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    <udiDi>05905331580229</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580229</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:46.571Z</lastUpdated>
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    <udiDi>05905331580212</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580212</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:45.366Z</lastUpdated>
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    <udiDi>05905331580205</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580205</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:44.177Z</lastUpdated>
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    <udiDi>05905331580199</udiDi>
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    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580199</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:41.775Z</lastUpdated>
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    <udiDi>05905331580182</udiDi>
    <basicUdiDi>590533158ECARE2.19TM</basicUdiDi>
    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580182</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:40.566Z</lastUpdated>
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    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580120</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:38.203Z</lastUpdated>
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    <udiDi>05905331580083</udiDi>
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    <tradeName>Comarch e-Care 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020692</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580083</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:57:36.969Z</lastUpdated>
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