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    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-39</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:21.176Z</lastUpdated>
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    <udiDi>00749756823692</udiDi>
    <basicUdiDi>B-00749756823692</basicUdiDi>
    <tradeName>Nasopharyngeal Temperature Probe</tradeName>
    <deviceName>Nasopharyngeal Temperature Probe</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:10.773Z</lastUpdated>
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    <udiDi>00749756820929</udiDi>
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    <tradeName>General Purpose Temperature Probe, Soft</tradeName>
    <deviceName>General Purpose Temperature Probe, Soft</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-02S412EU</reference>
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    <udiDi>00749756820912</udiDi>
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    <tradeName>General Purpose Temperature Probe, Soft</tradeName>
    <deviceName>General Purpose Temperature Probe, Soft</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-02S409EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:09.180Z</lastUpdated>
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    <udiDi>00749756791045</udiDi>
    <basicUdiDi>B-00749756791045</basicUdiDi>
    <tradeName>Nasopharyngeal Temperature Probe</tradeName>
    <deviceName>00749756791045</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-025400EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:04.364Z</lastUpdated>
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    <udiDi>00749756790932</udiDi>
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    <tradeName>Nasopharyngeal Temperature Probe</tradeName>
    <deviceName>Nasopharyngeal Temperature Probe</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-025409EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:03.564Z</lastUpdated>
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    <udiDi>00749756671361</udiDi>
    <basicUdiDi>B-00749756671361</basicUdiDi>
    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-37</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:02.763Z</lastUpdated>
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    <udiDi>00749756670203</udiDi>
    <basicUdiDi>B-00749756670203</basicUdiDi>
    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-36</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:01.978Z</lastUpdated>
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    <udiDi>00749756666688</udiDi>
    <basicUdiDi>B-00749756666688</basicUdiDi>
    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-38</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:57.979Z</lastUpdated>
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  <row>
    <udiDi>00749756596688</udiDi>
    <basicUdiDi>B-00749756596688</basicUdiDi>
    <tradeName>Tympanic Probe</tradeName>
    <deviceName>Tympanic Probe</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-090400EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:49.156Z</lastUpdated>
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    <udiDi>00749756596565</udiDi>
    <basicUdiDi>B-00749756596565</basicUdiDi>
    <tradeName>General Purpose Temperature Probe</tradeName>
    <deviceName>General Purpose Temperature Probe</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-020412EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:36.448Z</lastUpdated>
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    <udiDi>00749756596541</udiDi>
    <basicUdiDi>B-00749756596541</basicUdiDi>
    <tradeName>Skin Temperature Sensor</tradeName>
    <deviceName>Skin Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-010400EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:20.291Z</lastUpdated>
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    <udiDi>00749756301671</udiDi>
    <basicUdiDi>B-00749756301671</basicUdiDi>
    <tradeName>Skin Temperature Sensor</tradeName>
    <deviceName>Skin Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4499H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:39.451Z</lastUpdated>
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    <udiDi>00749756301657</udiDi>
    <basicUdiDi>B-00749756301657</basicUdiDi>
    <tradeName>General Purpose Temperature Probe</tradeName>
    <deviceName>General Purpose Temperature Probe</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4491H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:38.652Z</lastUpdated>
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    <udiDi>00749756266925</udiDi>
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    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-35</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:33.854Z</lastUpdated>
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    <udiDi>00749756138680</udiDi>
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    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-32</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:08.419Z</lastUpdated>
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    <udiDi>00749756049863</udiDi>
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    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:13.123Z</lastUpdated>
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    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-22</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:24:58.717Z</lastUpdated>
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    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-26</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:24:54.715Z</lastUpdated>
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    <udiDi>08681049550439</udiDi>
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    <tradeName>Heat Probe</tradeName>
    <deviceName>Heat Probe</deviceName>
    <manufacturerName>DİSPOSET TIBBİ ÜRÜNLER SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V03010201</emdnCode>
    <emdnDescription>TEMPERATURE MONITORING CUTANEOUS PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950 500 000 000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:23:41.084Z</lastUpdated>
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