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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>06939411508277</udiDi>
    <basicUdiDi>69394115OBSEGUV</basicUdiDi>
    <tradeName>Electrosurgical Generator</tradeName>
    <deviceName>Electrosurgical Generator</deviceName>
    <manufacturerName>Baisheng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024558</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OBS-350A  OBS-350B  OBS-300A   OBS-100A OBS-100B OBS-100C  OBS-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:10.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939411506648</udiDi>
    <basicUdiDi>69394115OBSDTVL</basicUdiDi>
    <tradeName>Trocar</tradeName>
    <deviceName>Disposable Trocar</deviceName>
    <manufacturerName>Baisheng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024558</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OBS-T05-A,OBS-T10-A,OBS-T10-AT,OBS-T12-AT,OBS-T05-B, OBS-T10-B, OBS-T10-BT,OBS-T03-S,OBS-T05-S,OBS-T10-CT,OBS-T12-CT</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:10.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939411505283</udiDi>
    <basicUdiDi>69394115OBSDSVJ</basicUdiDi>
    <tradeName>Disposable skin staplers</tradeName>
    <deviceName>Disposable skin staplers</deviceName>
    <manufacturerName>Baisheng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024558</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H02010101</emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OBS-MW,OBS-MH,OBS-MR,OBS-FW,OBS-FH,OBS-FR</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:08.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939411505030</udiDi>
    <basicUdiDi>69394115LBS4P</basicUdiDi>
    <tradeName>Physiotherapy Electrode</tradeName>
    <deviceName>Physiotherapy 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>N010201</emdnCode>
    <emdnDescription>TENS SYSTEM ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBS-Φ2, LBS-Φ3, LBS-Φ5, LBS-Φ7, LBS-Φ9, LBS-2×2, LBS-4×4, LBS- 5×5, LBS-2×3, LBS-5×3.5, LBS-6×4, LBS-6×5, LBS-8×4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:07.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938695581150</udiDi>
    <basicUdiDi>69386955HDKB</basicUdiDi>
    <tradeName>06938695581150</tradeName>
    <deviceName>Bone Cement Delivery System</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG8115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:48.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938695550026</udiDi>
    <basicUdiDi>69386955BAJK</basicUdiDi>
    <tradeName>Kyphoplasty Multifunctional Tool</tradeName>
    <deviceName>Kyphoplasty Multifunctional Tool</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG5100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:47.545Z</lastUpdated>
  </row>
</eudamedExport>