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<eudamedExport entity="devices">
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    <udiDi>06923310900379</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName>Breathing Circuit</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27A11</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:51.522Z</lastUpdated>
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  <row>
    <udiDi>06922166510503</udiDi>
    <basicUdiDi>69221665RTT001R4</basicUdiDi>
    <tradeName>Heated breathing tube</tradeName>
    <deviceName>Heated breathing tube</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>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YRT-T01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:12:36.754Z</lastUpdated>
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  <row>
    <udiDi>05404013003563</udiDi>
    <basicUdiDi>54040130000000000000169</basicUdiDi>
    <tradeName>WM 29067 prismaHYBERNITE</tradeName>
    <deviceName>Active non implantable respiratory devices.</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPE19018WT0019GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:58:19.236Z</lastUpdated>
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    <udiDi>05404013000234</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 12 ins+Inc</tradeName>
    <deviceName>Hybernite RT</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN12020BT1FQWBB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:58:17.621Z</lastUpdated>
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  <row>
    <udiDi>05404013000982</udiDi>
    <basicUdiDi>54040130000000000000169</basicUdiDi>
    <tradeName>S.Box HEATED TUBE</tradeName>
    <deviceName>Active non implantable respiratory devices.</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPE15018KT0030GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:49:51.717Z</lastUpdated>
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  <row>
    <udiDi>05404013000227</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 12 ex</tradeName>
    <deviceName>Hybernite RT</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN12016WT0FQWBB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:49:46.909Z</lastUpdated>
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  <row>
    <udiDi>05404013000807</udiDi>
    <basicUdiDi>54040130000000000000169</basicUdiDi>
    <tradeName>Hybernite HBT</tradeName>
    <deviceName>Active non implantable respiratory devices.</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HRN19018WT0ECWGC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:44:42.828Z</lastUpdated>
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  <row>
    <udiDi>05404013000210</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 12 ins</tradeName>
    <deviceName>Hybernite RT</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN12016BT1FTWBB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:44:27.445Z</lastUpdated>
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  <row>
    <udiDi>04719873290017</udiDi>
    <basicUdiDi>47198732930VR</basicUdiDi>
    <tradeName>04719873290017</tradeName>
    <deviceName>Heated-wire circuit</deviceName>
    <manufacturerName>DA CHUNG MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000037960</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3495</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:45:12.870Z</lastUpdated>
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  <row>
    <udiDi>04719873290000</udiDi>
    <basicUdiDi>47198732930VR</basicUdiDi>
    <tradeName>04719873290000</tradeName>
    <deviceName>Heated-wire circuit</deviceName>
    <manufacturerName>DA CHUNG MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000037960</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3490</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:32.653Z</lastUpdated>
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  <row>
    <udiDi>04710810107566</udiDi>
    <basicUdiDi>471081008NNH67S</basicUdiDi>
    <tradeName>NRV, Straight, 22F, 22/15, 30M, 6M</tradeName>
    <deviceName>NRV&amp;Valve</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010199</emdnCode>
    <emdnDescription>STANDARD BREATHING CIRCUITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0088</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:06.448Z</lastUpdated>
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  <row>
    <udiDi>04710810117626</udiDi>
    <basicUdiDi>471081008NNO287</basicUdiDi>
    <tradeName>Endo Mask, M w/Harness</tradeName>
    <deviceName>Endo Mask</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:24.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810115875</udiDi>
    <basicUdiDi>471081008RNP89J</basicUdiDi>
    <tradeName>CPAP Exhale Vent, 22M, 22M</tradeName>
    <deviceName>Reusable Other Connector</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:24.158Z</lastUpdated>
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  <row>
    <udiDi>04710810115622</udiDi>
    <basicUdiDi>471081008NNG17D</basicUdiDi>
    <tradeName>Adj PLS Valve, 2-10cmH2O, 22F</tradeName>
    <deviceName>Accessories</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0066</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:19.080Z</lastUpdated>
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    <udiDi>04710810105487</udiDi>
    <basicUdiDi>471081008NNHB8G</basicUdiDi>
    <tradeName>Silicone Single Limb Circuit, Adult</tradeName>
    <deviceName>Silicone Circuit</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0337</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:06.278Z</lastUpdated>
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  <row>
    <udiDi>04710810104732</udiDi>
    <basicUdiDi>471081008RNH58L</basicUdiDi>
    <tradeName>Valve for Manifold, Silicone, Green</tradeName>
    <deviceName>Reusable Manifold</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:05.462Z</lastUpdated>
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    <udiDi>04710810103872</udiDi>
    <basicUdiDi>471081008NNGN95</basicUdiDi>
    <tradeName>nCannula Kit, #0 w/nBonnet</tradeName>
    <deviceName>nCannula Kit</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0075</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:03.895Z</lastUpdated>
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    <udiDi>04710810104428</udiDi>
    <basicUdiDi>471081008NNRNA6</basicUdiDi>
    <tradeName>nAPV Circuit</tradeName>
    <deviceName>nAPV Circuit</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:59.856Z</lastUpdated>
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    <udiDi>04710810103001</udiDi>
    <basicUdiDi>471081008NNH17G</basicUdiDi>
    <tradeName>EVA Circuit, adult</tradeName>
    <deviceName>EVA  Circuit</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010102</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0235</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:58.394Z</lastUpdated>
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  <row>
    <udiDi>04710810089732</udiDi>
    <basicUdiDi>471081008NNQ28D</basicUdiDi>
    <tradeName>ESB Breathing Tube, 22F, 60cm</tradeName>
    <deviceName>Hytrel Hose</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:40.602Z</lastUpdated>
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</eudamedExport>