<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974529065434</udiDi>
    <basicUdiDi>697452906YSLXC</basicUdiDi>
    <tradeName>Single-Use Digital Flexible Ureteroscopes</tradeName>
    <deviceName>Single-Use Digital Flexible Ureteroscopes</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020713</emdnCode>
    <emdnDescription>URETERORENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XY-S600-A-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:26:59.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067998866</udiDi>
    <basicUdiDi>697452906AF3</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName>Disposable Anesthetic Masks</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMR53020H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:24:35.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971944913173</udiDi>
    <basicUdiDi>697194491AFG31-3HL</basicUdiDi>
    <tradeName>Disposable Dry Seal Chest Drainage Systems</tradeName>
    <deviceName>Disposable Dry Seal Chest Drainage Systems</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFG31-3 100003750</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:23:53.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971944913166</udiDi>
    <basicUdiDi>697194491AFG31-2HJ</basicUdiDi>
    <tradeName>Disposable Dry Seal Chest Drainage Systems</tradeName>
    <deviceName>Disposable Dry Seal Chest Drainage Systems</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFG31-2 100003749</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:23:52.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971944913159</udiDi>
    <basicUdiDi>697194491AFG31-1HG</basicUdiDi>
    <tradeName>Disposable Dry Seal Chest Drainage Systems</tradeName>
    <deviceName>Disposable Dry Seal Chest Drainage Systems</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFG31-1 100003748</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:23:51.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971944912862</udiDi>
    <basicUdiDi>697194491BN-OCRLM</basicUdiDi>
    <tradeName>Disposable Core Biopsy Instruments</tradeName>
    <deviceName>Disposable Core Biopsy Instruments</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020199</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100012181</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:23:50.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067998873</udiDi>
    <basicUdiDi>697452906AF3</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMR53021H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:07:43.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067998880</udiDi>
    <basicUdiDi>697452906AF3</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMR53022H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:07:43.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067998897</udiDi>
    <basicUdiDi>697452906AF3</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMR53023HH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:07:43.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067998903</udiDi>
    <basicUdiDi>697452906AF3</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMR53024HH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:07:43.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067998910</udiDi>
    <basicUdiDi>697452906AF3</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMR53025HH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:07:43.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067998927</udiDi>
    <basicUdiDi>697452906AF3</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMR53026HH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T04:07:43.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067978011</udiDi>
    <basicUdiDi>69420679BN-OCR-1SN</basicUdiDi>
    <tradeName>Disposable Core Biopsy Instruments</tradeName>
    <deviceName>Disposable Core Biopsy Instruments</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020199</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100022105</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:55.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067978004</udiDi>
    <basicUdiDi>69420679BN-OCR-1SN</basicUdiDi>
    <tradeName>Disposable Core Biopsy Instruments</tradeName>
    <deviceName>Disposable Core Biopsy Instruments</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020199</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100022104</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:54.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067977991</udiDi>
    <basicUdiDi>69420679BN-OCR-1SN</basicUdiDi>
    <tradeName>Disposable Core Biopsy Instruments</tradeName>
    <deviceName>Disposable Core Biopsy Instruments</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020199</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100022103</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:53.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067977984</udiDi>
    <basicUdiDi>69420679BN-OCR-1SN</basicUdiDi>
    <tradeName>Disposable Core Biopsy Instruments</tradeName>
    <deviceName>Disposable Core Biopsy Instruments</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020199</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100022090</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:45.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067977939</udiDi>
    <basicUdiDi>69420679SCFA</basicUdiDi>
    <tradeName>Single-use Digital Flexible Cystoscopes</tradeName>
    <deviceName>Single-use Digital Flexible Cystoscopes</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XY-SC54S-1R-0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:44.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067977922</udiDi>
    <basicUdiDi>69420679SCFA</basicUdiDi>
    <tradeName>Single-use Digital Flexible Cystoscopes</tradeName>
    <deviceName>Single-use Digital Flexible Cystoscopes</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XY-SC54S-0R-0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:43.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067977915</udiDi>
    <basicUdiDi>69420679SCFA</basicUdiDi>
    <tradeName>Single-use Digital Flexible Cystoscopes</tradeName>
    <deviceName>Single-use Digital Flexible Cystoscopes</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XY-SC54S-1S-0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:42.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942067977908</udiDi>
    <basicUdiDi>69420679SCFA</basicUdiDi>
    <tradeName>Single-use Digital Flexible Cystoscopes</tradeName>
    <deviceName>Single-use Digital Flexible Cystoscopes</deviceName>
    <manufacturerName>Ningbo Xinwell Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001084</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XY-SC54S-0S-0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T06:47:36.345Z</lastUpdated>
  </row>
</eudamedExport>