<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05059358038659</udiDi>
    <basicUdiDi>B-05059358038659</basicUdiDi>
    <tradeName>05059358038659</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED BALL GOLD, 70MM x 4.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-04031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:22.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038635</udiDi>
    <basicUdiDi>B-05059358038635</basicUdiDi>
    <tradeName>05059358038635</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED MATCH GOLD, 70MM X 3.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-03034</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:20.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038611</udiDi>
    <basicUdiDi>B-05059358038611</basicUdiDi>
    <tradeName>05059358038611</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 3.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-03031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:20.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038598</udiDi>
    <basicUdiDi>B-05059358038598</basicUdiDi>
    <tradeName>05059358038598</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED MATCH GOLD, 70MM X 2.2MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-02234</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:18.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038574</udiDi>
    <basicUdiDi>B-05059358038574</basicUdiDi>
    <tradeName>05059358038574</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 2.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-02031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:16.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038550</udiDi>
    <basicUdiDi>B-05059358038550</basicUdiDi>
    <tradeName>05059358038550</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED MATCH GOLD, 70MM X 1.7MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-01734</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:14.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038123</udiDi>
    <basicUdiDi>B-05059358038123</basicUdiDi>
    <tradeName>05059358038123</tradeName>
    <deviceName>BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 6.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-06051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:13.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038109</udiDi>
    <basicUdiDi>B-05059358038109</basicUdiDi>
    <tradeName>05059358038109</tradeName>
    <deviceName>BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 5.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-05051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:12.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038086</udiDi>
    <basicUdiDi>B-05059358038086</basicUdiDi>
    <tradeName>05059358038086</tradeName>
    <deviceName>BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 4.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-04051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:09.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358036495</udiDi>
    <basicUdiDi>B-05059358036495</basicUdiDi>
    <tradeName>05059358036495</tradeName>
    <deviceName>BUR - 3.18MM, X COARSE DIAMOND CYL, 140MM X 6.5MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D14-06582</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:08.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358036471</udiDi>
    <basicUdiDi>B-05059358036471</basicUdiDi>
    <tradeName>05059358036471</tradeName>
    <deviceName>BUR - 3.18MM, X COARSE DIAMOND CYL, 90MM X 6.5MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D09-06582</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:07.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358036457</udiDi>
    <basicUdiDi>B-05059358036457</basicUdiDi>
    <tradeName>05059358036457</tradeName>
    <deviceName>BUR - 2.38MM, X COARSE DIAMOND CYL, 150MM X 6.5MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C15-06582</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:05.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141641</udiDi>
    <basicUdiDi>B-04946329141641</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.149</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:07.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141610</udiDi>
    <basicUdiDi>B-04946329141610</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.146</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:07.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141603</udiDi>
    <basicUdiDi>B-04946329141603</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.145</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-39</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:06.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141597</udiDi>
    <basicUdiDi>B-04946329141597</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.144</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-38</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:05.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141580</udiDi>
    <basicUdiDi>B-04946329141580</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.143</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-37</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:01.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141573</udiDi>
    <basicUdiDi>B-04946329141573</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.142</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-36</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:00.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141566</udiDi>
    <basicUdiDi>B-04946329141566</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.141</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:22:59.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946329141245</udiDi>
    <basicUdiDi>B-04946329141245</basicUdiDi>
    <tradeName>Sugita Titanium Aneurysm Clip II Standard Fenestrated Type No.109</tradeName>
    <deviceName>Sugita Titanium Aneurysm Clip II</deviceName>
    <manufacturerName>MIZUHO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000019215</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-006-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:22:59.123Z</lastUpdated>
  </row>
</eudamedExport>