<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033860000127</udiDi>
    <basicUdiDi>8033860BIOAFT01SR</basicUdiDi>
    <tradeName>SPEEDYBELL</tradeName>
    <deviceName>SOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC)</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</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>SB1415EC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:28:56.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860000103</udiDi>
    <basicUdiDi>8033860BIOAFT01SR</basicUdiDi>
    <tradeName>SPEEDYBELL</tradeName>
    <deviceName>SOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC)</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</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>SB1615EC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:21:35.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860000080</udiDi>
    <basicUdiDi>8033860BIOAFT01SR</basicUdiDi>
    <tradeName>SPEEDYBELL</tradeName>
    <deviceName>SOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC)</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</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>SB1610EC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:11:07.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666570028</udiDi>
    <basicUdiDi>697046733EBN-CBNKT</basicUdiDi>
    <tradeName>06936666570028</tradeName>
    <deviceName>Automatic Core Biopsy Instrument</deviceName>
    <manufacturerName>Zhejiang CuraWay Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025983</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BN-OCR-13/1408/Ⅰ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:07:42.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414662573</udiDi>
    <basicUdiDi>6954414600300001F7</basicUdiDi>
    <tradeName>Automatic Disposable Biopsy Needle</tradeName>
    <deviceName>Automatic Disposable Biopsy Needle</deviceName>
    <manufacturerName>Canyon Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000022663</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N70116160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:27:08.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937893902811</udiDi>
    <basicUdiDi>69378939F4066</basicUdiDi>
    <tradeName>06937893902811</tradeName>
    <deviceName>Disposable Biopsy Device</deviceName>
    <manufacturerName>Tonglu Qianyan Medtech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017342</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F40202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:05:14.916Z</lastUpdated>
  </row>
  <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>04571225309835</udiDi>
    <basicUdiDi>4571225300004UC</basicUdiDi>
    <tradeName>TSK PRIMECUTⅡ BIOPSY NEEDLE</tradeName>
    <deviceName>TSK PRIMECUTⅡ BIOPSY NEEDLE</deviceName>
    <manufacturerName>TSK Laboratory, Japan</manufacturerName>
    <manufacturerSrn>JP-MF-000008485</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRM-161502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:01:58.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571225305158</udiDi>
    <basicUdiDi>4571225300002U8</basicUdiDi>
    <tradeName>TSK ACECUT BIOPSY NEEDLE</tradeName>
    <deviceName>TSK ACECUT BIOPSY NEEDLE</deviceName>
    <manufacturerName>TSK Laboratory, Japan</manufacturerName>
    <manufacturerSrn>JP-MF-000008485</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACE-140751C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:01:56.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262410686007</udiDi>
    <basicUdiDi>426241068BIMBAM27</basicUdiDi>
    <tradeName>04262410686007</tradeName>
    <deviceName>(Semi)Automatic Biopsy Needle</deviceName>
    <manufacturerName>ITP Innovative Tomography Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008634</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>BAM18/20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:31:47.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052440105953</udiDi>
    <basicUdiDi>B-08052440105953</basicUdiDi>
    <tradeName>LightCut Plus</tradeName>
    <deviceName>LightCut Plus</deviceName>
    <manufacturerName>M.D.L. S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000011599</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD1810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:56:00.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930474014385</udiDi>
    <basicUdiDi>69304740CXN23</basicUdiDi>
    <tradeName>HUAXING</tradeName>
    <deviceName>Disposable Coaxial Biopsy Needle</deviceName>
    <manufacturerName>Jiangsu Province Huaxing Medical Apparatus Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022111</manufacturerSrn>
    <authorisedRepresentativeName>AKUS INNOVATION IN ANAESTHESIA SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018792</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15G*50mm</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:04:55.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414662580</udiDi>
    <basicUdiDi>6954414600300001F7</basicUdiDi>
    <tradeName>Automatic Disposable Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canyon Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000022663</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N70116180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T09:38:05.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414662597</udiDi>
    <basicUdiDi>6954414600300001F7</basicUdiDi>
    <tradeName>Automatic Disposable Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canyon Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000022663</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N70116200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T09:38:05.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414662603</udiDi>
    <basicUdiDi>6954414600300001F7</basicUdiDi>
    <tradeName>Automatic Disposable Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canyon Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000022663</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N70116250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T09:38:05.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414662610</udiDi>
    <basicUdiDi>6954414600300001F7</basicUdiDi>
    <tradeName>Automatic Disposable Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canyon Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000022663</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N70118100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T09:38:05.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414662627</udiDi>
    <basicUdiDi>6954414600300001F7</basicUdiDi>
    <tradeName>Automatic Disposable Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canyon Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000022663</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N70118130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T09:38:05.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414662634</udiDi>
    <basicUdiDi>6954414600300001F7</basicUdiDi>
    <tradeName>Automatic Disposable Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canyon Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000022663</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0102010101</emdnCode>
    <emdnDescription>SHEARING BIOPSY NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N70118160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T09:38:05.390Z</lastUpdated>
  </row>
</eudamedExport>