<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>06923980101083</udiDi>
    <basicUdiDi>69239801ND2PAPT</basicUdiDi>
    <tradeName>DispoBag, Child w/Pop-Off, Mask</tradeName>
    <deviceName>Disposable Manual Resuscitator</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:33.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980101014</udiDi>
    <basicUdiDi>69239801ND2RDQ7</basicUdiDi>
    <tradeName>Diverter Cap w/Valve, 30F</tradeName>
    <deviceName>Disposable Valve &amp; Manifold</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>R028001</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:31.091Z</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>06923980100147</udiDi>
    <basicUdiDi>69239801ND2CCNQ</basicUdiDi>
    <tradeName>MR-100 Reservoir Bag, 600ml</tradeName>
    <deviceName>Disposable Breathing bag</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:28.698Z</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>06923980100000</udiDi>
    <basicUdiDi>69239801ND2IBP8</basicUdiDi>
    <tradeName>Filter, Hydrophobic 4F, 4M</tradeName>
    <deviceName>Disposable Filter</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>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:24.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310903141</udiDi>
    <basicUdiDi>69233109PA21LW</basicUdiDi>
    <tradeName>Tracheal Tube Introducer</tradeName>
    <deviceName>Tracheal Tube Introducer</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>R018004</emdnCode>
    <emdnDescription>INTUBATION DEVICE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA210106</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:47.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310903004</udiDi>
    <basicUdiDi>69233109PA19019G</basicUdiDi>
    <tradeName>Naso-Pharyngeal Airway</tradeName>
    <deviceName>Naso-Pharyngeal Airway</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010101</emdnCode>
    <emdnDescription>NASOPHARYNGEAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA190130</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:45.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310902908</udiDi>
    <basicUdiDi>69233109PA04018G</basicUdiDi>
    <tradeName>Oral-Pharyngeal Airway</tradeName>
    <deviceName>Oral-Pharyngeal Airway</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010102</emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA040104</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:43.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310902861</udiDi>
    <basicUdiDi>69233109PA18019B</basicUdiDi>
    <tradeName>Intubating Stylet</tradeName>
    <deviceName>Intubating Stylet</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R018004</emdnCode>
    <emdnDescription>INTUBATION DEVICE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA180106</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:41.926Z</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>06923310902502</udiDi>
    <basicUdiDi>69233109PA36MB</basicUdiDi>
    <tradeName>Catheter Fixation Device</tradeName>
    <deviceName>Catheter Fixation Device</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R018002</emdnCode>
    <emdnDescription>INTUBATION DEVICE SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA3601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:37.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310902533</udiDi>
    <basicUdiDi>69233109PA40619A</basicUdiDi>
    <tradeName>Manual Resuscitator</tradeName>
    <deviceName>Manual Resuscitator</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA40611111</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:35.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901291</udiDi>
    <basicUdiDi>69233109PA19029J</basicUdiDi>
    <tradeName>Naso-Pharyngeal Airway</tradeName>
    <deviceName>Naso-Pharyngeal Airway</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010101</emdnCode>
    <emdnDescription>NASOPHARYNGEAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA190230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:25.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310901208</udiDi>
    <basicUdiDi>69233109PA04028J</basicUdiDi>
    <tradeName>Oral-Pharyngeal Airway</tradeName>
    <deviceName>Oral-Pharyngeal Airway</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010102</emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA040204</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:25.126Z</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>06923310900942</udiDi>
    <basicUdiDi>69233109PA61029D</basicUdiDi>
    <tradeName>Laryngeal Mask</tradeName>
    <deviceName>Laryngeal 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>R01020102</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA610210</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:05.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900874</udiDi>
    <basicUdiDi>69233109PA61019B</basicUdiDi>
    <tradeName>Laryngeal Mask</tradeName>
    <deviceName>Laryngeal 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>R01020102</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA610110</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:05.824Z</lastUpdated>
  </row>
</eudamedExport>