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    <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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    <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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    <udiDi>05391530290654</udiDi>
    <basicUdiDi>539153029026005FN</basicUdiDi>
    <tradeName>Sedaconda ACD Starter Kit</tradeName>
    <deviceName>Sedaconda ACD Starter Kit</deviceName>
    <manufacturerName>Sedana Medical Limited</manufacturerName>
    <manufacturerSrn>IE-PR-000001737</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020399</emdnCode>
    <emdnDescription>ANESTHESIA AND RESUSCITATION CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2026030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:53.802Z</lastUpdated>
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    <udiDi>05060120950567</udiDi>
    <basicUdiDi>506012095Accessories264</basicUdiDi>
    <tradeName>Spiroguard Adaptor</tradeName>
    <deviceName>Anaesthesia and Resuscitation Connectors</deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020302</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2802/17BAEB001/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:28:01.591Z</lastUpdated>
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    <udiDi>05060120950024</udiDi>
    <basicUdiDi>506012095Accessories162</basicUdiDi>
    <tradeName>Attachment</tradeName>
    <deviceName>Catheter Mounts</deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A620/60/61BAUA020/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:27:51.175Z</lastUpdated>
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    <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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    <udiDi>04719873433490</udiDi>
    <basicUdiDi>471096971TCF17II010163</basicUdiDi>
    <tradeName>Free Trachea Closed Suction Set</tradeName>
    <deviceName>Closed Suction System</deviceName>
    <manufacturerName>Pacific Hospital Supply Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007247</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020202</emdnCode>
    <emdnDescription>MOBILE CATHETER MOUNTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T20030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:53.304Z</lastUpdated>
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    <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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    <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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    <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>
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    <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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    <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>04710810114809</udiDi>
    <basicUdiDi>471081008NNBW98</basicUdiDi>
    <tradeName>Guedel Airway 120mm, Purple</tradeName>
    <deviceName>Oropharyngeal airway</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</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>AW0003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:18.263Z</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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    <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>04710810104459</udiDi>
    <basicUdiDi>471081008NNCN8R</basicUdiDi>
    <tradeName>nBonnet, #1/XS, Green</tradeName>
    <deviceName>nBonnet</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</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>AN0005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:04.711Z</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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    <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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