<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00749756129596</udiDi>
    <basicUdiDi>B-00749756129596</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>88-000013C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:55.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756129589</udiDi>
    <basicUdiDi>B-00749756129589</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>88-000012C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:54.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756129572</udiDi>
    <basicUdiDi>B-00749756129572</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>88-000011C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:53.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756129541</udiDi>
    <basicUdiDi>B-00749756129541</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>88-000041</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:53.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756129459</udiDi>
    <basicUdiDi>B-00749756129459</basicUdiDi>
    <tradeName>Electrosurgical Tip Cleaner</tradeName>
    <deviceName>Electrosurgical Tip Cleaner</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>Z12010999</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:49.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756128735</udiDi>
    <basicUdiDi>B-00749756128735</basicUdiDi>
    <tradeName>Instrument Pad</tradeName>
    <deviceName>Instrument Pad</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>25-003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:48.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756128728</udiDi>
    <basicUdiDi>B-00749756128728</basicUdiDi>
    <tradeName>Instrument Pad</tradeName>
    <deviceName>Instrument Pad</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>25-004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:47.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756126403</udiDi>
    <basicUdiDi>B-00749756126403</basicUdiDi>
    <tradeName>Electrosurgical Pencil</tradeName>
    <deviceName>Electrosurgical Pencil</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>88-000032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:46.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756126397</udiDi>
    <basicUdiDi>B-00749756126397</basicUdiDi>
    <tradeName>Electrosurgical Pencil</tradeName>
    <deviceName>Electrosurgical Pencil</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>88-000031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:42.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756126373</udiDi>
    <basicUdiDi>B-00749756126373</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>88-000013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:41.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756126366</udiDi>
    <basicUdiDi>B-00749756126366</basicUdiDi>
    <tradeName>Bipolar Cord</tradeName>
    <deviceName>Bipolar Cord</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>88-001000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:41.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756126359</udiDi>
    <basicUdiDi>B-00749756126359</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>88-000012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:40.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756126342</udiDi>
    <basicUdiDi>B-00749756126342</basicUdiDi>
    <tradeName>Electrosurgical Pencil</tradeName>
    <deviceName>Electrosurgical Pencil</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:25.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756126335</udiDi>
    <basicUdiDi>B-00749756126335</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>88-000011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:24.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756119917</udiDi>
    <basicUdiDi>B-00749756119917</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>26-005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:20.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756119597</udiDi>
    <basicUdiDi>B-00749756119597</basicUdiDi>
    <tradeName>Suture Boot</tradeName>
    <deviceName>Suture Boots</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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-706</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:19.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756119511</udiDi>
    <basicUdiDi>B-00749756119511</basicUdiDi>
    <tradeName>Impervious Stockinette</tradeName>
    <deviceName>Impervious Stockinette</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>M010199</emdnCode>
    <emdnDescription>COTTON WADDING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9978-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:18.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756053280</udiDi>
    <basicUdiDi>B-00749756053280</basicUdiDi>
    <tradeName>Electrosurgical Pencil</tradeName>
    <deviceName>Electrosurgical Pencil</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>88-000002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:17.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756049917</udiDi>
    <basicUdiDi>B-00749756049917</basicUdiDi>
    <tradeName>Stockinette</tradeName>
    <deviceName>Stockinette</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>M010199</emdnCode>
    <emdnDescription>COTTON WADDING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9510-48</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:13.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756049863</udiDi>
    <basicUdiDi>B-00749756049863</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-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:25:13.123Z</lastUpdated>
  </row>
</eudamedExport>