<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06923980102127</udiDi>
    <basicUdiDi>69239801ND2SJQN</basicUdiDi>
    <tradeName>Gas Sampling Line, 300cm, 4M</tradeName>
    <deviceName>Disposable Ventilation Circuit</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></emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0005</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:58.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102110</udiDi>
    <basicUdiDi>69239801ND2ICPA</basicUdiDi>
    <tradeName>HMEF w/Luer,  22F/15M, 22/15mm</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></emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:57.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980101984</udiDi>
    <basicUdiDi>69239801ND1CBNH</basicUdiDi>
    <tradeName>Berman Airway 50mm</tradeName>
    <deviceName>Oropharyngeal airway</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></emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:57.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980101885</udiDi>
    <basicUdiDi>69239801ND1CANF</basicUdiDi>
    <tradeName>Guedel Airway 40mm, Pink</tradeName>
    <deviceName>Oropharyngeal airway</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></emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:56.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980101502</udiDi>
    <basicUdiDi>69239801ND2OAPQ</basicUdiDi>
    <tradeName>PEEP Valve, 5~20 cmH2O, 30F</tradeName>
    <deviceName>Disposable PEEP VALVE</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></emdnCode>
    <emdnDescription>RESPIRATORY BALLONS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0004</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:55.422Z</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></emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:54.621Z</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></emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:53.818Z</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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:53.019Z</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></emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:52.221Z</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></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:51.413Z</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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:50.628Z</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></emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:49.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100406</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Sil.Flex Mask, #1</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:01.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100413</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Sil.Flex Mask, #2</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0016</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:00.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100420</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Silicone Mask, #3</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:00.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100437</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Silicone Mask, #4</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0084</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:00.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100444</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Silicone Mask, #5</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:00.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100468</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Silicone Mask, #4</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:00.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100475</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Silicone Mask, #5</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:00.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100482</udiDi>
    <basicUdiDi>69239801NR2KBSG</basicUdiDi>
    <tradeName>Rendell Baker Silicone Mask, #0</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0019</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:44:00.841Z</lastUpdated>
  </row>
</eudamedExport>