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<eudamedExport entity="devices">
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    <udiDi>00850040313192</udiDi>
    <basicUdiDi>0850040313CFKU4</basicUdiDi>
    <tradeName>Carbon filter cartridge and check valve</tradeName>
    <deviceName>Carbon Filter Cartridge and Check Valve</deviceName>
    <manufacturerName>Javid de Mexico S. De R.L. De C.V. (resplabs)</manufacturerName>
    <manufacturerSrn>MX-MF-000040624</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B09ZVN9LP3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:23:56.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850030671882</udiDi>
    <basicUdiDi>0850040313CN5Y</basicUdiDi>
    <tradeName>CPAP Adapter – Compatible with AirMini Hose Connector</tradeName>
    <deviceName>CPAP Adapter – Compatible with AirMini Hose Connector</deviceName>
    <manufacturerName>Javid de Mexico S. De R.L. De C.V. (resplabs)</manufacturerName>
    <manufacturerSrn>MX-MF-000040624</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHAMC2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:22:12.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850021345365</udiDi>
    <basicUdiDi>0850040313HC5R</basicUdiDi>
    <tradeName>CPAP Hose Coves</tradeName>
    <deviceName>CPAP Hose Covers</deviceName>
    <manufacturerName>RespiraSource, OPC</manufacturerName>
    <manufacturerSrn>PH-MF-000013799</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHHC6FT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:50.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011958704</udiDi>
    <basicUdiDi>0850040313ML6S</basicUdiDi>
    <tradeName>CPAP Mask Wipes</tradeName>
    <deviceName>CPAP Mask Liners</deviceName>
    <manufacturerName>RespiraSource, OPC</manufacturerName>
    <manufacturerSrn>PH-MF-000013799</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHMLFF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:39.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011958605</udiDi>
    <basicUdiDi>0850040313CH5L</basicUdiDi>
    <tradeName>CPAP Hose</tradeName>
    <deviceName>CPAP Hose</deviceName>
    <manufacturerName>Javid de Mexico S. De R.L. De C.V. (resplabs)</manufacturerName>
    <manufacturerSrn>MX-MF-000040624</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHTBBLK6FT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:38.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011958513</udiDi>
    <basicUdiDi>0850040313MW7G</basicUdiDi>
    <tradeName>CPAP Mask Wipes</tradeName>
    <deviceName>CPAP Mask Wipes</deviceName>
    <manufacturerName>Javid de Mexico S. De R.L. De C.V. (resplabs)</manufacturerName>
    <manufacturerSrn>MX-MF-000040624</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHCMKWP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:38.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011958308</udiDi>
    <basicUdiDi>0850040313SC6S</basicUdiDi>
    <tradeName>CPAP Headgear Strap Covers</tradeName>
    <deviceName>CPAP Headgear Strap Covers</deviceName>
    <manufacturerName>RespiraSource, OPC</manufacturerName>
    <manufacturerSrn>PH-MF-000013799</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B07X1SRX5D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:37.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011958124</udiDi>
    <basicUdiDi>0850040313CF5G</basicUdiDi>
    <tradeName>CPAP Filters</tradeName>
    <deviceName>CPAP Filters</deviceName>
    <manufacturerName>Javid de Mexico S. De R.L. De C.V. (resplabs)</manufacturerName>
    <manufacturerSrn>MX-MF-000040624</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B07Z7C4PLZ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:18:31.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198843003545</udiDi>
    <basicUdiDi>08479460BTCL</basicUdiDi>
    <tradeName>00198843003545</tradeName>
    <deviceName>Infant Flow LP System</deviceName>
    <manufacturerName>ZOLL Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021386</manufacturerSrn>
    <authorisedRepresentativeName>ZOLL International Holding B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012554</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>777040XS-40</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:28.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198843002777</udiDi>
    <basicUdiDi>08479460BGBS</basicUdiDi>
    <tradeName>00198843002777</tradeName>
    <deviceName>bellavista Accessories</deviceName>
    <manufacturerName>ZOLL Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021386</manufacturerSrn>
    <authorisedRepresentativeName>ZOLL International Holding B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012554</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010599</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>304.585.001-40</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:25.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198843001145</udiDi>
    <basicUdiDi>08479460BFBQ</basicUdiDi>
    <tradeName>00198843001145</tradeName>
    <deviceName>iFlow</deviceName>
    <manufacturerName>ZOLL Medical Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021386</manufacturerSrn>
    <authorisedRepresentativeName>ZOLL International Holding B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012554</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019085</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301.328.020-40</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:58:24.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100159</udiDi>
    <basicUdiDi>08436851NKV440JX</basicUdiDi>
    <tradeName>Nihon Kohden NKV-440 Ventilator System</tradeName>
    <deviceName>Nihon Kohden NKV-440 Ventilator System</deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-440</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:19:42.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100005</udiDi>
    <basicUdiDi>08436851NKV550K7</basicUdiDi>
    <tradeName>Nihon Kohden NKV-550 Series Ventilator System</tradeName>
    <deviceName>Nihon Kohden NKV-550 Series Ventilator System</deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-550-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:19:42.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953043844</udiDi>
    <basicUdiDi>08406821BUG004777P</basicUdiDi>
    <tradeName>Serenity S Vaporizer GEHC SEV Easy-Fil EN-UK</tradeName>
    <deviceName>Serenity S, Serenity T</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS22G01NN07</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:57:51.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>00637320061239</udiDi>
    <basicUdiDi>0637320GO2VENT6123TL</basicUdiDi>
    <tradeName>00637320061239</tradeName>
    <deviceName>VORTRAN Automatic Resuscitator (VAR)</deviceName>
    <manufacturerName>Vortran Medical Technology 1 Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020318</manufacturerSrn>
    <authorisedRepresentativeName>Europecert UG (haftungsbeschränkt)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6123</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:07:04.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959421189</udiDi>
    <basicUdiDi>0606959BM769NB</basicUdiDi>
    <tradeName>DreamStation 2 Roll Stand</tradeName>
    <deviceName>DreamStation 2 Roll Stand</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1145156</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:50.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959412514</udiDi>
    <basicUdiDi>0606959BM224LU</basicUdiDi>
    <tradeName>DC Battery Adapter Cable</tradeName>
    <deviceName>DreamStation DC Power Cords</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>532209</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:49.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959412491</udiDi>
    <basicUdiDi>0606959BM140LM</basicUdiDi>
    <tradeName>Shielded DC Cord</tradeName>
    <deviceName>Power Supply</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001956</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:45.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959401556</udiDi>
    <basicUdiDi>0606959BM698ND</basicUdiDi>
    <tradeName>System One 60 Series Shielded DC Cord System</tradeName>
    <deviceName>System One 60 Series Power Cables</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1099011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:44.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959064447</udiDi>
    <basicUdiDi>0606959BM756N2</basicUdiDi>
    <tradeName>DreamStation Go Battery Pack</tradeName>
    <deviceName>DreamStation Go Battery Pack</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133281</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:39.055Z</lastUpdated>
  </row>
</eudamedExport>