<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00749756158794</udiDi>
    <basicUdiDi>B-00749756158794</basicUdiDi>
    <tradeName>Insufflation Tubing,Laparoscopic</tradeName>
    <deviceName>Insufflation Tubing,Laparoscopic</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>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28-0209</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:13.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157827</udiDi>
    <basicUdiDi>B-00749756157827</basicUdiDi>
    <tradeName>Electrode, Blade 1" (2.5cm)</tradeName>
    <deviceName>Electrode, Blade 1" (2.5cm)</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000M13</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:13.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157810</udiDi>
    <basicUdiDi>B-00749756157810</basicUdiDi>
    <tradeName>Electrode, Needle 1" (2.5cm)</tradeName>
    <deviceName>Electrode, Needle 1" (2.5cm)</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000M12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:12.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157803</udiDi>
    <basicUdiDi>B-00749756157803</basicUdiDi>
    <tradeName>Electrode, Blade 6" (15.2cm)</tradeName>
    <deviceName>Electrode, Blade 6" (15.2cm)</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000M11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:11.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157780</udiDi>
    <basicUdiDi>B-00749756157780</basicUdiDi>
    <tradeName>Holster</tradeName>
    <deviceName>Holster</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>88-000008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:07.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157773</udiDi>
    <basicUdiDi>B-00749756157773</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Button Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Button Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-001522</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:06.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157766</udiDi>
    <basicUdiDi>B-00749756157766</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Rocker Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Rocker Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-001521</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:05.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157759</udiDi>
    <basicUdiDi>B-00749756157759</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Button Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Button Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-001502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:04.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157483</udiDi>
    <basicUdiDi>B-00749756157483</basicUdiDi>
    <tradeName>Surgical Skin Markers</tradeName>
    <deviceName>Surgical Skin Markers</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>26-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:14.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756157476</udiDi>
    <basicUdiDi>B-00749756157476</basicUdiDi>
    <tradeName>Surgical Skin Markers</tradeName>
    <deviceName>Surgical Skin Markers</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>26-004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:14.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756152624</udiDi>
    <basicUdiDi>B-00749756152624</basicUdiDi>
    <tradeName>Insufflation Tubing,Laparoscopic</tradeName>
    <deviceName>Insufflation Tubing,Laparoscopic</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>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28-0210</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:13.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756145732</udiDi>
    <basicUdiDi>B-00749756145732</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>28-0102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:12.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756138680</udiDi>
    <basicUdiDi>B-00749756138680</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-32</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:08.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756138208</udiDi>
    <basicUdiDi>B-00749756138208</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Button Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Button Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:07.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756136013</udiDi>
    <basicUdiDi>B-00749756136013</basicUdiDi>
    <tradeName>Coated Blade Electrode</tradeName>
    <deviceName>Coated Blade Electrode</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000M13C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:06.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756135993</udiDi>
    <basicUdiDi>B-00749756135993</basicUdiDi>
    <tradeName>Coated Needle Electrode</tradeName>
    <deviceName>Coated Needle Electrode</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000M12C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:06.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756134323</udiDi>
    <basicUdiDi>B-00749756134323</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Button Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Button Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000052</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:01.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756134316</udiDi>
    <basicUdiDi>B-00749756134316</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Rocker Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Rocker Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:01.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756134309</udiDi>
    <basicUdiDi>B-00749756134309</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Button Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Button Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:26:00.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756134293</udiDi>
    <basicUdiDi>B-00749756134293</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Rocker Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Rocker Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:59.599Z</lastUpdated>
  </row>
</eudamedExport>