<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05407005001202</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-10-EN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001219</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-14-EN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001226</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-14-EN1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001233</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome Bone</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-BO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001240</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome Bone</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-10-BO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001295</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐19-FL</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>PERENDOSCOPIC BRONCHIAL BIOPSY NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05407005001295</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>05407005001301</udiDi>
    <basicUdiDi>5407005001035PU</basicUdiDi>
    <tradeName>Spirotome SS‐16-FL</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>05407005001301</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:29:56.396Z</lastUpdated>
  </row>
</eudamedExport>