<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942382601106</udiDi>
    <basicUdiDi>B-06942382601106</basicUdiDi>
    <tradeName>INSPIRATION Medical Tracheostomy Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:42:28.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382601113</udiDi>
    <basicUdiDi>B-06942382601113</basicUdiDi>
    <tradeName>INSPIRATION Medical Tracheostomy Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11202001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:42:17.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091922674</udiDi>
    <basicUdiDi>B-06972091922674</basicUdiDi>
    <tradeName>INSPIRATION Medical Tracheostomy Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRACHEOSTOMY O2 SUPPLIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11201001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:36:45.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972091928113</udiDi>
    <basicUdiDi>697209192ETU34KM</basicUdiDi>
    <tradeName>Disposable electronic ureteroscope</tradeName>
    <deviceName>Disposable electronic ureteroscope</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020713</emdnCode>
    <emdnDescription>URETERORENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06972091928113</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:39:11.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927907</udiDi>
    <basicUdiDi>697209192TTI35NY</basicUdiDi>
    <tradeName>BM Tracheostomy Tube with Inner Cannula</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>224 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:33:01.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927792</udiDi>
    <basicUdiDi>697209192RTTU35WM</basicUdiDi>
    <tradeName>BM Reinforced Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010201</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:33:00.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927587</udiDi>
    <basicUdiDi>697209192RTE35MN</basicUdiDi>
    <tradeName>BM Reinforced Tracheostomy Tube with Evacuation Lumen</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105020201</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>228 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:57.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927488</udiDi>
    <basicUdiDi>697209192TTE35NC</basicUdiDi>
    <tradeName>BM Tracheostomy Tube with Evacuation Lumen</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:56.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927402</udiDi>
    <basicUdiDi>697209192RTTC35TT</basicUdiDi>
    <tradeName>BM Reinforced Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105020201</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>226 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:55.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927310</udiDi>
    <basicUdiDi>697209192ETE31GX</basicUdiDi>
    <tradeName>BM Endotracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Endotracheal Tube with Evacuation Lumen</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01030201</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22060002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:53.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091924708</udiDi>
    <basicUdiDi>697209192SRB37M8</basicUdiDi>
    <tradeName>BM Stone Retrieval Baskets</tradeName>
    <deviceName>Stone Retrieval Baskets</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090101</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL BASKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407 17 01 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:51.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091927006</udiDi>
    <basicUdiDi>697209192UDBC40KD</basicUdiDi>
    <tradeName>BM Ureteral Dilation Balloon Catheters</tradeName>
    <deviceName>Ureteral Dilation Balloon Catheters</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>406 04 12 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:48.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091926733</udiDi>
    <basicUdiDi>697209192UED38KF</basicUdiDi>
    <tradeName>BM Ureteral Dilators</tradeName>
    <deviceName>Ureteral Dilators</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405 06 22 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:48.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091923176</udiDi>
    <basicUdiDi>697209192SMT08NQ</basicUdiDi>
    <tradeName>BM Stomach Tubes</tradeName>
    <deviceName>Stomach Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50106002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:30.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091922285</udiDi>
    <basicUdiDi>697209192NPA12JE</basicUdiDi>
    <tradeName>BM Nasopharyngeal Airways</tradeName>
    <deviceName>Nasopharyngeal Airways</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010101</emdnCode>
    <emdnDescription>NASOPHARYNGEAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20330002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:29.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091922063</udiDi>
    <basicUdiDi>697209192ETI17HR</basicUdiDi>
    <tradeName>BM Endotracheal Tube Introducers (bougie)</tradeName>
    <deviceName>Endotracheal Tube Introducers (bougie)</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R018004</emdnCode>
    <emdnDescription>INTUBATION DEVICE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20406002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:28.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091922025</udiDi>
    <basicUdiDi>697209192IBS17GR</basicUdiDi>
    <tradeName>BM Intubating Stylets</tradeName>
    <deviceName>Intubating Stylets</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R018004</emdnCode>
    <emdnDescription>INTUBATION DEVICE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20606002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:28.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091921547</udiDi>
    <basicUdiDi>697209192EBTR15JH</basicUdiDi>
    <tradeName>BM Endobronchial Tubes</tradeName>
    <deviceName>Endobronchial Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040102</emdnCode>
    <emdnDescription>ENDOBRONCHIAL OROPHARYNGEAL TUBES, RIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>229 28 00 2R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:22.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091921486</udiDi>
    <basicUdiDi>697209192EBTL15HK</basicUdiDi>
    <tradeName>BM Endobronchial Tubes</tradeName>
    <deviceName>Endobronchial Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040202</emdnCode>
    <emdnDescription>ENDOBRONCHIAL OROPHARYNGEAL TUBES, LEFT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>229 28 00 2L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:20.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972091921332</udiDi>
    <basicUdiDi>697209192TTTU35XF</basicUdiDi>
    <tradeName>BM Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22330002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:20.019Z</lastUpdated>
  </row>
</eudamedExport>