<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06948538360170</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>N4 Nasal Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NM4(Small)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:48.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360163</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>N4 Nasal Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NM4(Medium)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:47.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360156</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>N4 Nasal Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NM4(Large)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:41.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360088</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>F2 Full Face Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-FM2(Small)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:40.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360071</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>F2 Full Face Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-FM2(Medium)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:38.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360064</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>F2 Full Face Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-FM2(Large)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:37.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360026</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>iVolve F1A Full Face Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-FM1A(Small)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:31.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360019</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>iVolve F1A Full Face Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-FM1A(Medium)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:30.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538360002</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>iVolve F1A Full Face Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-FM1A(Large)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:29.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538320020</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>iVolve N2 Nasal Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-NM2(Large)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:28.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538320013</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>iVolve N2 Nasal Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-NM2(Medium)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:22.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538320006</udiDi>
    <basicUdiDi>69485383STA01Z3</basicUdiDi>
    <tradeName>iVolve N2 Nasal Mask</tradeName>
    <deviceName>Mask</deviceName>
    <manufacturerName>BMC Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010157</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMC-NM2(Small)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:20.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430426024</udiDi>
    <basicUdiDi>694643043723402Q8</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0101001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:09:32.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430426017</udiDi>
    <basicUdiDi>694643043723402Q8</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0101002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:09:30.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430426000</udiDi>
    <basicUdiDi>694643043723402Q8</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0101003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:09:25.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430419613</udiDi>
    <basicUdiDi>694643043723402Q8</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0101003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:56:39.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430419606</udiDi>
    <basicUdiDi>694643043723402Q8</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0101002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:56:38.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430419590</udiDi>
    <basicUdiDi>694643043723402Q8</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0101001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:56:37.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430413154</udiDi>
    <basicUdiDi>694643043723403QA</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0102003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:41:22.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946430413147</udiDi>
    <basicUdiDi>694643043723403QA</basicUdiDi>
    <tradeName>Silicone CPAP Mask</tradeName>
    <deviceName>Silicone CPAP Mask</deviceName>
    <manufacturerName>Xiamen Compower Medical Tech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011703</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCM0102002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:41:21.110Z</lastUpdated>
  </row>
</eudamedExport>