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    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>ECG, Respiration and SpO2 Transmitter, model LX-7230N, LX-7230KM</tradeName>
    <deviceName>Measuring and Monitoring Equipment for Vital Signs</deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX-7230N</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:51:33.993Z</lastUpdated>
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  <row>
    <udiDi>04538612054181</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>Disposable Portable Case</tradeName>
    <deviceName>Accessories for Measuring and Monitoring Equipment for Vital Signs</deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-720D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:51:07.464Z</lastUpdated>
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    <udiDi>04260498565269</udiDi>
    <basicUdiDi>426049856DE55252NMTELWB</basicUdiDi>
    <tradeName>NR-314-T</tradeName>
    <deviceName>NR Series</deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR314T-D-00E-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:02:52.940Z</lastUpdated>
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    <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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    <udiDi>08594212770025</udiDi>
    <basicUdiDi>0859421277KARDIAI0023F</basicUdiDi>
    <tradeName>Kardi Ai</tradeName>
    <deviceName>Kardi Ai</deviceName>
    <manufacturerName>KARDI AI Technologies s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000026438</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kardi Ai</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:56:09.177Z</lastUpdated>
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  <row>
    <udiDi>07290110258429</udiDi>
    <basicUdiDi>0729011720NM2069202TELDH</basicUdiDi>
    <tradeName>NR-314-T</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>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR314T-D-00E-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:32.103Z</lastUpdated>
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    <udiDi>07290110258443</udiDi>
    <basicUdiDi>0729011720NM2069202TELDH</basicUdiDi>
    <tradeName>NR-314-T</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>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR314T-D-00U-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:48:53.290Z</lastUpdated>
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    <udiDi>07290008960380</udiDi>
    <basicUdiDi>B-07290008960380</basicUdiDi>
    <tradeName>smartheart</tradeName>
    <deviceName>smartheart</deviceName>
    <manufacturerName>SHL Telemedicine International Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000021473</manufacturerSrn>
    <authorisedRepresentativeName>SHL Telemedizin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016273</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-XXX-X</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:35.466Z</lastUpdated>
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    <udiDi>07290008960359</udiDi>
    <basicUdiDi>B-07290008960359</basicUdiDi>
    <tradeName>smartheart</tradeName>
    <deviceName>smartheart</deviceName>
    <manufacturerName>SHL Telemedicine International Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000021473</manufacturerSrn>
    <authorisedRepresentativeName>SHL Telemedizin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016273</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-467-X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:33.870Z</lastUpdated>
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  <row>
    <udiDi>07290008960274</udiDi>
    <basicUdiDi>B-07290008960274</basicUdiDi>
    <tradeName>Cardio'B</tradeName>
    <deviceName>Cardio'B</deviceName>
    <manufacturerName>SHL Telemedicine International Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000021473</manufacturerSrn>
    <authorisedRepresentativeName>SHL Telemedizin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016273</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-410-0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:31.463Z</lastUpdated>
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  <row>
    <udiDi>07290008960250</udiDi>
    <basicUdiDi>B-07290008960250</basicUdiDi>
    <tradeName>07290008960250</tradeName>
    <deviceName>CardioSen'C</deviceName>
    <manufacturerName>SHL Telemedicine International Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000021473</manufacturerSrn>
    <authorisedRepresentativeName>SHL Telemedizin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016273</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-430-0 to E-434-0, E-436-0, E-445-0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:59:29.859Z</lastUpdated>
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  <row>
    <udiDi>00850490007238</udiDi>
    <basicUdiDi>B-00850490007238</basicUdiDi>
    <tradeName>VitalPatch</tradeName>
    <deviceName>VitalPatch</deviceName>
    <manufacturerName>VitalConnect, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010637</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3037-01</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:44.749Z</lastUpdated>
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  <row>
    <udiDi>04538612914171</udiDi>
    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>ECG &amp; Respiration Transmitter  model LX-8100 type LX-8100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX-8100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:51.054Z</lastUpdated>
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    <udiDi>04538612914256</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>Disposable Case （For LX-8100）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-810D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:51.030Z</lastUpdated>
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    <udiDi>04538612914263</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>Neck Strap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAT-03A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:51.003Z</lastUpdated>
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  <row>
    <udiDi>04538612914454</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>SpO2 Cap (For Transmitter)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAT-04A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.743Z</lastUpdated>
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  <row>
    <udiDi>04538612914584</udiDi>
    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>ECG, Respiration and SpO2 Transmitter  model LX-8300M type LX-8300M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX-8300M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.444Z</lastUpdated>
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    <udiDi>04538612914683</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>SpO2 Cap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAT-05A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612914690</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>ECG Cap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAT-06A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.370Z</lastUpdated>
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  <row>
    <udiDi>04538612916274</udiDi>
    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX-1300M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.623Z</lastUpdated>
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