<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04034393770680</udiDi>
    <basicUdiDi>4034393CPTGEN2BWH</basicUdiDi>
    <tradeName>GYN LAP Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66823813-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:29:04.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>04034393777733</udiDi>
    <basicUdiDi>4034393CPTGEN2BWH</basicUdiDi>
    <tradeName>Colon Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66816791-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:28:34.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>04034393779140</udiDi>
    <basicUdiDi>4034393CPTGEN2BWH</basicUdiDi>
    <tradeName>Endo-Sigma-Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66810420-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:28:34.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>04034393782867</udiDi>
    <basicUdiDi>4034393CPTGEN2BWH</basicUdiDi>
    <tradeName>LSK-Set Gyn</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66818213-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:28:33.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>04034393797731</udiDi>
    <basicUdiDi>4034393CPTGEN2BWH</basicUdiDi>
    <tradeName>Tumor-OP-Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66810273-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:28:28.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223004462</udiDi>
    <basicUdiDi>B-05051223004462</basicUdiDi>
    <tradeName>Electrode Tip Cleaner</tradeName>
    <deviceName>Electrode Tip Cleaner</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5204</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:56.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756566995</udiDi>
    <basicUdiDi>B-00749756566995</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>88-000223</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:19.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756301954</udiDi>
    <basicUdiDi>B-00749756301954</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>88-000222</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:41.063Z</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>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>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>
</eudamedExport>