<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05407005001035</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐08‐10</tradeName>
    <deviceName>Spirotome</deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001035</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:59:10.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001028</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐08‐15</tradeName>
    <deviceName>Spirotome</deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001028</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:50:59.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001011</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐08‐20</tradeName>
    <deviceName>Spirotome</deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001011</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:27.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005000038</udiDi>
    <basicUdiDi>540700500SpirotomeG6</basicUdiDi>
    <tradeName>Spirotome</tradeName>
    <deviceName>Spirotome</deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010299</emdnCode>
    <emdnDescription>BIOPSY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-08-10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:26.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001127</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐14‐10</tradeName>
    <deviceName>Spirotome</deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001127</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:58:40.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001042</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐08‐08</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001042</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001059</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐08‐06</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001059</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001066</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐10‐20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001066</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001073</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐10‐15</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001073</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001080</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐10‐10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001080</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001097</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐10‐08</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001097</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001103</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐10‐06</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001103</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001110</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐14‐15</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001110</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001134</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐14‐08</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001134</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001141</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐14-06</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001141</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001158</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐08-MR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001158</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001165</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐08‐MR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001165</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001172</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome Cervicore</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-08*EN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001189</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-08-CE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001196</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome Endo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioncise NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000875</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-08-EN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.488Z</lastUpdated>
  </row>
</eudamedExport>