<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00884838040069</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak Airway Adapter Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1103414</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838040076</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak Airway Adapter Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1103415</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838044395</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak CO2 Oral Nasal Cannula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1105098</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838044401</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak CO2 Oral Nasal Cannula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1105099</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838044418</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak CO2/O2 Oral Nasal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1105100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838044425</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak CO2/O2 Oral Nasal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1105135</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838044524</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak CO2 Sampling Extension Line</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1105136</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838044531</udiDi>
    <basicUdiDi>0884838BM631T3</basicUdiDi>
    <tradeName>CapnoTrak O2 Delivery Extension Line</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1105137</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:11.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838056336</udiDi>
    <basicUdiDi>0884838BM737TL</basicUdiDi>
    <tradeName>CapnoTrak Dehumidification Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1103417</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:10.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838059399</udiDi>
    <basicUdiDi>0884838BM736TJ</basicUdiDi>
    <tradeName>Sample Line-Female Luer Connector</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Novametrix, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007951</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3476-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:48:10.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>04931921898413</udiDi>
    <basicUdiDi>4931921MD10023BH</basicUdiDi>
    <tradeName>SpO2 Connection Cord JL-930P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K930</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:07:53.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>04931921903568</udiDi>
    <basicUdiDi>4931921MD10001B7</basicUdiDi>
    <tradeName>SpO2 Connection Cord JL-430U</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K939B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:07:52.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>04931921904411</udiDi>
    <basicUdiDi>4931921MD10021BD</basicUdiDi>
    <tradeName>FLOW ADAPTER TF-130P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P917A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:07:52.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414221812</udiDi>
    <basicUdiDi>7332414VA0000432Z</basicUdiDi>
    <tradeName>PRISMALUNG+</tradeName>
    <deviceName>PrismaLung+</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>955742MDR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:46.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974226681425</udiDi>
    <basicUdiDi>697422668RVLW2</basicUdiDi>
    <tradeName>ETCO2 Sampling Cannula</tradeName>
    <deviceName>ETCO2 Sampling Cannula</deviceName>
    <manufacturerName>Dongguan Rongrui-Century Science &amp; Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032795</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVL006(Nose L)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:45:59.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972984450055</udiDi>
    <basicUdiDi>697298445521QH</basicUdiDi>
    <tradeName>06972984450055</tradeName>
    <deviceName>Capnography CO2 sample line</deviceName>
    <manufacturerName>Qinhuangdao Kapunuomaite Medical Equipment S&amp;T Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5210S-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:27:34.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>14931921900359</udiDi>
    <basicUdiDi>4931921MD10022BF</basicUdiDi>
    <tradeName>Nasal Adapter YG-225T</tradeName>
    <deviceName>Patient monitoring system module, carbon dioxide</deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V936A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:00:42.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>14931921889739</udiDi>
    <basicUdiDi>4931921MD10021BD</basicUdiDi>
    <tradeName>SAMPLING LINE YG-610P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V920A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:36:26.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>14931921898380</udiDi>
    <basicUdiDi>4931921MD10023BH</basicUdiDi>
    <tradeName>Attachment Tape XL YS-102P2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P264C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:36:25.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>14931921900373</udiDi>
    <basicUdiDi>4931921MD10022BF</basicUdiDi>
    <tradeName>Pediatric Nasal Adapter YG-235T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V937A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:36:25.864Z</lastUpdated>
  </row>
</eudamedExport>