<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-M9242-SP-90V4</udiDi>
    <basicUdiDi>B-M9242-SP-90V4</basicUdiDi>
    <tradeName>SpiroSafe Disposable Flow Transducer</tradeName>
    <deviceName>Medikro® SpiroSafe Disposable Flow Transducer</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9242-SP-90</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:14.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9242-B-SP-90HC</udiDi>
    <basicUdiDi>B-M9242-B-SP-90HC</basicUdiDi>
    <tradeName>SpiroSafe Disposable Flow Transducers</tradeName>
    <deviceName>Medikro® SpiroSafe Disposable Flow Transducer</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9242-B-SP-90</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:10.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9242-B-100FL</udiDi>
    <basicUdiDi>B-M9242-B-100FL</basicUdiDi>
    <tradeName>SpiroSafe Disposable Flow Transducers</tradeName>
    <deviceName>Medikro® SpiroSafe Disposable Flow Transducer</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9242-B-100</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:09.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-M9242-10077</udiDi>
    <basicUdiDi>B-M9242-10077</basicUdiDi>
    <tradeName>SpiroSafe Disposable Flow Transducers</tradeName>
    <deviceName>Medikro® SpiroSafe Disposable Flow Transducer</deviceName>
    <manufacturerName>Medikro Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000011841</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M9242-100</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:52:09.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS2002R0</udiDi>
    <basicUdiDi>B-M766AS2002R0</basicUdiDi>
    <tradeName>Freestyle Comfort</tradeName>
    <deviceName>Freestyle Comfort</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS200-2R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:47:12.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS2002020</udiDi>
    <basicUdiDi>B-M766AS2002020</basicUdiDi>
    <tradeName>Freestyle Comfort</tradeName>
    <deviceName>Freestyle Comfort</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS200-202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:55.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS20020</udiDi>
    <basicUdiDi>B-M766AS20020</basicUdiDi>
    <tradeName>Freestyle Comfort</tradeName>
    <deviceName>Freestyle Comfort</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS200-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:55.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS2001020</udiDi>
    <basicUdiDi>B-M766AS2001020</basicUdiDi>
    <tradeName>Freestyle Comfort</tradeName>
    <deviceName>Freestyle Comfort</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS200-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:52.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS0992100</udiDi>
    <basicUdiDi>B-M766AS0992100</basicUdiDi>
    <tradeName>NewLife Intensity 10</tradeName>
    <deviceName>NewLife Intensity 10</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS099-210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:42.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS0991030</udiDi>
    <basicUdiDi>B-M766AS0991030</basicUdiDi>
    <tradeName>NewLife Intensity 10</tradeName>
    <deviceName>NewLife Intensity 10</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS099-103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:41.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS099100</udiDi>
    <basicUdiDi>B-M766AS099100</basicUdiDi>
    <tradeName>NewLife Intensity 10</tradeName>
    <deviceName>NewLife Intensity 10</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS099-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:37.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS09870</udiDi>
    <basicUdiDi>B-M766AS09870</basicUdiDi>
    <tradeName>VisionAire 5</tradeName>
    <deviceName>VisionAire 5</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS098-7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:36.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS09850</udiDi>
    <basicUdiDi>B-M766AS09850</basicUdiDi>
    <tradeName>VisionAire 5</tradeName>
    <deviceName>VisionAire 5</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS098-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:35.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS094-1030</udiDi>
    <basicUdiDi>B-M766AS094-1030</basicUdiDi>
    <tradeName>NewLife Intensity 8</tradeName>
    <deviceName>NewLife Intensity 8</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS094-103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:30.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766AS005-5550</udiDi>
    <basicUdiDi>B-M766AS005-5550</basicUdiDi>
    <tradeName>NewLife Elite</tradeName>
    <deviceName>NewLife Elite</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS005-555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:28.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766940001SEQ0</udiDi>
    <basicUdiDi>B-M766940001SEQ0</basicUdiDi>
    <tradeName>SAROS</tradeName>
    <deviceName>SAROS</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9400-01-SEQ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:27.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7666900C1SEQ0</udiDi>
    <basicUdiDi>B-M7666900C1SEQ0</basicUdiDi>
    <tradeName>Eclipse</tradeName>
    <deviceName>Eclipse</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900-C1-SEQ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:24.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766690008SEQ0</udiDi>
    <basicUdiDi>B-M766690008SEQ0</basicUdiDi>
    <tradeName>ECLIPSE</tradeName>
    <deviceName>Eclipse</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900-08-SEQ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:24.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>M766150670210</udiDi>
    <basicUdiDi>B-M766150670210</basicUdiDi>
    <tradeName>Companion 5</tradeName>
    <deviceName>Companion 5 Oxygen Concentrator</deviceName>
    <manufacturerName>CAIRE Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013030</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15067021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:46:09.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-LEX-2YZ</udiDi>
    <basicUdiDi>B-LEX-2YZ</basicUdiDi>
    <tradeName>Lung Exerciser</tradeName>
    <deviceName>Lung Exerciser</deviceName>
    <manufacturerName>Disposafe Health &amp; Lifecare Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000020265</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEX-2</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:49:15.007Z</lastUpdated>
  </row>
</eudamedExport>