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<eudamedExport entity="devices">
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    <udiDi>00749756984195</udiDi>
    <basicUdiDi>B-00749756984195</basicUdiDi>
    <tradeName>Esophageal Stethoscope w/Temperature Sensor</tradeName>
    <deviceName>Esophageal Stethoscope w/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>V03010201</emdnCode>
    <emdnDescription>TEMPERATURE MONITORING CUTANEOUS PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1024215VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:54.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756984089</udiDi>
    <basicUdiDi>B-00749756984089</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>M1024231VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:51.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756984072</udiDi>
    <basicUdiDi>B-00749756984072</basicUdiDi>
    <tradeName>00749756984072</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>V03010201</emdnCode>
    <emdnDescription>TEMPERATURE MONITORING CUTANEOUS PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1024229VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:50.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756984058</udiDi>
    <basicUdiDi>B-00749756984058</basicUdiDi>
    <tradeName>Esophageal Stethoscope With Temperature Sensor</tradeName>
    <deviceName>Esophageal Stethoscope With 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>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1024212VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:49.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756984041</udiDi>
    <basicUdiDi>B-00749756984041</basicUdiDi>
    <tradeName>Esophageal Stethoscope With Temperature Sensor</tradeName>
    <deviceName>Esophageal Stethoscope With 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>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1024205VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:47.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756984034</udiDi>
    <basicUdiDi>B-00749756984034</basicUdiDi>
    <tradeName>Tympanic Probe without foam</tradeName>
    <deviceName>Tympanic Probe without foam</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>M1024237VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:45.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756984010</udiDi>
    <basicUdiDi>B-00749756984010</basicUdiDi>
    <tradeName>Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>Foley Catheter with 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>U0199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1024244VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:43.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756984003</udiDi>
    <basicUdiDi>B-00749756984003</basicUdiDi>
    <tradeName>Foley Catheter With Temperature Sensor</tradeName>
    <deviceName>Foley Catheter With 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>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1024242VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:42.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756983990</udiDi>
    <basicUdiDi>B-00749756983990</basicUdiDi>
    <tradeName>Foley Catheter With Temperature Sensor</tradeName>
    <deviceName>Foley Catheter With 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>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1024239VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:41.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756983983</udiDi>
    <basicUdiDi>B-00749756983983</basicUdiDi>
    <tradeName>00749756983983</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>M1024222VY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:38.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756873369</udiDi>
    <basicUdiDi>B-00749756873369</basicUdiDi>
    <tradeName>Surgical Skin Markers, Prep Resistant</tradeName>
    <deviceName>Surgical Skin Markers, Prep Resistant</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9004</emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26-003PR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:37.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756873352</udiDi>
    <basicUdiDi>B-00749756873352</basicUdiDi>
    <tradeName>Surgical Skin Markers, Prep Resistant</tradeName>
    <deviceName>Surgical Skin Markers, Prep Resistant</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9004</emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26-001PR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:36.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756873376</udiDi>
    <basicUdiDi>B-00749756873376</basicUdiDi>
    <tradeName>Surgical Skin Markers, Prep Resistant</tradeName>
    <deviceName>Surgical Skin Markers, Prep Resistant</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9004</emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26-005PR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:34.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756869881</udiDi>
    <basicUdiDi>B-00749756869881</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-39</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:21.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756866828</udiDi>
    <basicUdiDi>B-00749756866828</basicUdiDi>
    <tradeName>Saf-T-Glove</tradeName>
    <deviceName>Saf-T-Glove</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM3613</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:17.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756866811</udiDi>
    <basicUdiDi>B-00749756866811</basicUdiDi>
    <tradeName>Saf-T-Glove</tradeName>
    <deviceName>Saf-T-Glove</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM3612</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:16.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756866804</udiDi>
    <basicUdiDi>B-00749756866804</basicUdiDi>
    <tradeName>Saf-T-Glove</tradeName>
    <deviceName>Saf-T-Glove</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM3611</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:15.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756846738</udiDi>
    <basicUdiDi>B-00749756846738</basicUdiDi>
    <tradeName>DEFOGGER Anti Fog Kit</tradeName>
    <deviceName>DEFOGGER Anti Fog Kit</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12021199</emdnCode>
    <emdnDescription>ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28-0102B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:14.788Z</lastUpdated>
  </row>
  <row>
    <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>
    <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>2070720-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:10.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756820929</udiDi>
    <basicUdiDi>B-00749756820929</basicUdiDi>
    <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>
    <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>81-02S412EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:09.983Z</lastUpdated>
  </row>
</eudamedExport>