<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06948538365595</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B30AT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:59.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365588</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B30VT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:56.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365571</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B30T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:55.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365564</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B25VT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:54.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365472</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 LAB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:48.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365465</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 B30SV</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:47.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365458</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 B30VT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:46.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365441</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 B25VT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:44.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365434</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 B25A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:37.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365427</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 B25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:36.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365410</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 B20A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:35.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365380</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S LAB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:34.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365373</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:28.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365366</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B25A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:26.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365359</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:25.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365342</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:24.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365335</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B20A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:18.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365328</udiDi>
    <basicUdiDi>69485383RIV01ZL</basicUdiDi>
    <tradeName>BPAP System</tradeName>
    <deviceName>Non-Invasive Ventilator</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2S B20S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:17.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365137</udiDi>
    <basicUdiDi>69485383ST001WK</basicUdiDi>
    <tradeName>RESmart GII BPAP System</tradeName>
    <deviceName>Sleep Apnea Therapy Device</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:16.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948538365120</udiDi>
    <basicUdiDi>69485383ST001WK</basicUdiDi>
    <tradeName>RESmart GII BPAP System</tradeName>
    <deviceName>Sleep Apnea Therapy Device</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T-20A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:17:14.945Z</lastUpdated>
  </row>
</eudamedExport>