<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06923980103681</udiDi>
    <basicUdiDi>69239801FD2ACKS</basicUdiDi>
    <tradeName>Neb.Easy AM-1 Mask, Infant w/Tube</tradeName>
    <deviceName>Disposable Aerosol therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0053</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:43.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102806</udiDi>
    <basicUdiDi>69239801ND2KAPC</basicUdiDi>
    <tradeName>AM-6 Trachea Mask, Adult</tradeName>
    <deviceName>Disposable Mask</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:11.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102790</udiDi>
    <basicUdiDi>69239801ND2MEPS</basicUdiDi>
    <tradeName>OM-4 Trachea Mask, Adult w/Tubing</tradeName>
    <deviceName>Disposable Oxygen therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010205</emdnCode>
    <emdnDescription>TRACHEOSTOMY O2 SUPPLIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:07.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102776</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-2 HiO2 Mask, Adult w/Tubing, PVC Bag</tradeName>
    <deviceName>Disposable Oxygen therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0093</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:06.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102752</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>OM-2 Mask, Child w/Tubing</tradeName>
    <deviceName>Disposable Oxygen therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:05.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102745</udiDi>
    <basicUdiDi>69239801ND2MGPW</basicUdiDi>
    <tradeName>AM-3 Adj-Venturi Mask, Adult w/Tube</tradeName>
    <deviceName>Disposable Oxygen therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0079</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:05.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102448</udiDi>
    <basicUdiDi>69239801FD2AAKN</basicUdiDi>
    <tradeName>LVN Nebulizer Kit</tradeName>
    <deviceName>Disposable Aerosol therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0099</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:55.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102202</udiDi>
    <basicUdiDi>69239801NR1EARP</basicUdiDi>
    <tradeName>Headgear for CPAP Mask, L, Silicone</tradeName>
    <deviceName>Reusable Headgear</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:43.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980101250</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Airsoft Mask, #0</tradeName>
    <deviceName>Disposable Mask</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:35.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100390</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Sil.Flex Mask, #0</tradeName>
    <deviceName>Reusable Mask</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:29.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100826</udiDi>
    <basicUdiDi>69239801ND2NBPP</basicUdiDi>
    <tradeName>C22 Star Lumen Tubing, 200cm, 6M</tradeName>
    <deviceName>Disposable Oxygen tubing</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:27.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310902755</udiDi>
    <basicUdiDi>69233109PA05LY</basicUdiDi>
    <tradeName>Oxygen Mask</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:41.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310902748</udiDi>
    <basicUdiDi>69233109PA17M7</basicUdiDi>
    <tradeName>Oxygen Mask with Reservoir Bag</tradeName>
    <deviceName>Oxygen Mask with Reservoir Bag</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA1700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:39.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901420</udiDi>
    <basicUdiDi>69233109PA06M2</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName>Nebulizer kit</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0611</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:23.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900850</udiDi>
    <basicUdiDi>69233109PA16079D</basicUdiDi>
    <tradeName>Gas tube</tradeName>
    <deviceName>Gas tube</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160707</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:04.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900751</udiDi>
    <basicUdiDi>69233109PA31028Q</basicUdiDi>
    <tradeName>Anaesthetic Mask</tradeName>
    <deviceName>Anaesthetic Mask</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA310200</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:03.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900669</udiDi>
    <basicUdiDi>69233109PA16M5</basicUdiDi>
    <tradeName>Nasal Cannula</tradeName>
    <deviceName>Nasal Cannula</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160512</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:57.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900638</udiDi>
    <basicUdiDi>69233109PA16018Z</basicUdiDi>
    <tradeName>Nasal Cannula</tradeName>
    <deviceName>Nasal Cannula</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:57.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900430</udiDi>
    <basicUdiDi>69233109PA160395</basicUdiDi>
    <tradeName>Nasal Cannula</tradeName>
    <deviceName>Nasal Cannula</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA160301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:55.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166510510</udiDi>
    <basicUdiDi>69221665YNM001QC</basicUdiDi>
    <tradeName>Nasal Mask</tradeName>
    <deviceName>Sleep apnea breathing therapy mask</deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MN02001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:15:23.774Z</lastUpdated>
  </row>
</eudamedExport>