<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936603200353</udiDi>
    <basicUdiDi>69709008510147Y</basicUdiDi>
    <tradeName>Valve Kit for FUJIFILM 700 Series Endoscopes</tradeName>
    <deviceName>Disposable Endoscopy Adapter Sets</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AWV-KIT-01-FJ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:26:35.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936603200063</udiDi>
    <basicUdiDi>69709008510217V</basicUdiDi>
    <tradeName>Injection needle</tradeName>
    <deviceName>Disposable Endoscope Injection Needles</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-O18-22-5-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:26:34.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936603200025</udiDi>
    <basicUdiDi>69709008510137W</basicUdiDi>
    <tradeName>Disposable Biopsy Forceps</tradeName>
    <deviceName>Disposable Biopsy Forceps</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0308010101</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400109010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:26:33.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936603200018</udiDi>
    <basicUdiDi>697090085101888</basicUdiDi>
    <tradeName>neocleancap® Type B</tradeName>
    <deviceName>Clean Connecting Tubes</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0280</emdnCode>
    <emdnDescription>GASTROINTESTINAL TUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222665</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:26:31.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970453271194</udiDi>
    <basicUdiDi>697045327FG900AP</basicUdiDi>
    <tradeName>Fractional CO2 Laser Therapy System</tradeName>
    <deviceName>Fractional CO2 Laser Therapy System</deviceName>
    <manufacturerName>Beijing ADSS Development Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013103</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011005</emdnCode>
    <emdnDescription>CARBON DIOXIDE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fractional CO2 Laser Therapy System</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:23:50.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937278617637</udiDi>
    <basicUdiDi>697046733EBNQY</basicUdiDi>
    <tradeName>06937278617637</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</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:23:45.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937278615831</udiDi>
    <basicUdiDi>697046733PBNSP</basicUdiDi>
    <tradeName>06937278615831</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-6/1208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:23:44.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937278618771</udiDi>
    <basicUdiDi>697046733CBNQN</basicUdiDi>
    <tradeName>06937278618771</tradeName>
    <deviceName>Disposable Coaxial Biopsy Needle</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-MAR-5/11030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:23:42.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937278617873</udiDi>
    <basicUdiDi>697046733MBNS8</basicUdiDi>
    <tradeName>06937278617873</tradeName>
    <deviceName>Semi-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-4/1208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:23:41.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937278614483</udiDi>
    <basicUdiDi>697046733ABNQC</basicUdiDi>
    <tradeName>06937278614483</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-1/1208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:23:27.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937278603722</udiDi>
    <basicUdiDi>697046733PTCTP</basicUdiDi>
    <tradeName>06937278603722</tradeName>
    <deviceName>Disposable Biopsy Needle</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>A01020102</emdnCode>
    <emdnDescription>ASPIRATION FINE NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BN-MAR-1/1204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:23:26.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666569770</udiDi>
    <basicUdiDi>697046733EBN-CBNKT</basicUdiDi>
    <tradeName>06936666569770</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-13/1820/Ⅰ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:48.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666556596</udiDi>
    <basicUdiDi>697046733MBN-CBNQ3</basicUdiDi>
    <tradeName>06936666556596</tradeName>
    <deviceName>Semi-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-4/1208/Ⅰ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:44.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666554110</udiDi>
    <basicUdiDi>697046733ABN-CBNHP</basicUdiDi>
    <tradeName>06936666554110</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-1/1208/Ⅰ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:43.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666526667</udiDi>
    <basicUdiDi>697046733GW-1JW</basicUdiDi>
    <tradeName>06936666526667</tradeName>
    <deviceName>Breast Lesion Localization Wire</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>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-QS 20-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:43.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666526643</udiDi>
    <basicUdiDi>697046733GW2U</basicUdiDi>
    <tradeName>06936666526643</tradeName>
    <deviceName>Breast Lesion Localization Wire</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>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-Q 20-140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:42.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666524854</udiDi>
    <basicUdiDi>697046733PBN-CBNRN</basicUdiDi>
    <tradeName>06936666524854</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-9/2016/Ⅰ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:41.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936666510727</udiDi>
    <basicUdiDi>697046733DJZN</basicUdiDi>
    <tradeName>06936666510727</tradeName>
    <deviceName>Cura RF Electrode</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K02030101</emdnCode>
    <emdnDescription>RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-15s15FO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:40.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939411511192</udiDi>
    <basicUdiDi>69394115302V9</basicUdiDi>
    <tradeName>Disposable ECG Electrodes</tradeName>
    <deviceName>Disposable ECG Electrodes</deviceName>
    <manufacturerName>Baisheng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024558</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302A, 302B, 302C, 302D, 302E, 302F, 302G, 302H, 302I, 302J, 302K, 302L, 302M, 302N, 302O, 302P</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:12.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939411511048</udiDi>
    <basicUdiDi>69394115301V7</basicUdiDi>
    <tradeName>Disposable ECG Electrodes</tradeName>
    <deviceName>Disposable ECG Electrodes</deviceName>
    <manufacturerName>Baisheng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024558</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301A, 301B, 301C, 301D, 301E, 301F, 301G, 301H, 301I, 301J, 301K, 301L,  301M, 301N, 301O, 301P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:11.671Z</lastUpdated>
  </row>
</eudamedExport>