<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04250892905945</udiDi>
    <basicUdiDi>42508929012112AG3</basicUdiDi>
    <tradeName>04250892905945</tradeName>
    <deviceName>SentrySuite 3.30</deviceName>
    <manufacturerName>Jaeger Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159082</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-770968</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:48:32.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250892905617</udiDi>
    <basicUdiDi>42508929011861QE</basicUdiDi>
    <tradeName>04250892905617</tradeName>
    <deviceName>Accessory patient gas pathway expiratory only</deviceName>
    <manufacturerName>Jaeger Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159085</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-861360</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:48:28.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413410545</udiDi>
    <basicUdiDi>42504134Dual_DruckT4</basicUdiDi>
    <tradeName>Dual pressure sensor for Pneumotachograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159008</emdnCode>
    <emdnDescription>PNEUMOTACHOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS272</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:37:02.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406319</udiDi>
    <basicUdiDi>42504134CPAP-senN2</basicUdiDi>
    <tradeName>CPAP Pressure Sensor (0-24 mbar)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159008</emdnCode>
    <emdnDescription>PNEUMOTACHOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN639</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:11.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405893</udiDi>
    <basicUdiDi>42504134PlethUT</basicUdiDi>
    <tradeName>PlethRing Sensor Medium (19mm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159007</emdnCode>
    <emdnDescription>BODY PLETHYSMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABP510/M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:05.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413409112</udiDi>
    <basicUdiDi>42504134Dual_DruckT4</basicUdiDi>
    <tradeName>Dual Pressure Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159008</emdnCode>
    <emdnDescription>PNEUMOTACHOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOS200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:41.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405886</udiDi>
    <basicUdiDi>42504134PlethUT</basicUdiDi>
    <tradeName>PlethRing Sensor Small (17mm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159007</emdnCode>
    <emdnDescription>BODY PLETHYSMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABP510/S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:02.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405060</udiDi>
    <basicUdiDi>42504134FlowPS2</basicUdiDi>
    <tradeName>Flow pressure sensor for SOMNOtouch NIBP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159008</emdnCode>
    <emdnDescription>PNEUMOTACHOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOS100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:31:38.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>03858893574750</udiDi>
    <basicUdiDi>385889357AWOX0016J</basicUdiDi>
    <tradeName>03858893574750</tradeName>
    <deviceName>oxygen concentrator</deviceName>
    <manufacturerName>Awatar Medical Aid d.o.o.</manufacturerName>
    <manufacturerSrn>HR-MF-000025777</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW OXC001  5.S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:00:51.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947832500701</udiDi>
    <basicUdiDi>69478325CNDX2024010800WZ</basicUdiDi>
    <tradeName>Compressor Nebulizer</tradeName>
    <deviceName>Compressor Nebulizer</deviceName>
    <manufacturerName>Shenzhen Aeon Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012690</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A500LWDC04</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:49:04.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05030267160389</udiDi>
    <basicUdiDi>05030267PEPTHERER</basicUdiDi>
    <tradeName>05030267160389</tradeName>
    <deviceName>Positive Expiratory Pressure (PEP) Therapy device</deviceName>
    <manufacturerName>Intersurgical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004798</manufacturerSrn>
    <authorisedRepresentativeName>UAB Intersurgical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LT-AR-000003907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8020045</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:44:21.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>04065803201005</udiDi>
    <basicUdiDi>B-04065803201005</basicUdiDi>
    <tradeName>Diffustik</tradeName>
    <deviceName>Diffustik</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159003</emdnCode>
    <emdnDescription>DIFFUSION ANALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>913857</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:49:16.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640156398489</udiDi>
    <basicUdiDi>764015639MDA0307_1M8</basicUdiDi>
    <tradeName>MED-111 Compressor nebulizer</tradeName>
    <deviceName>Compressor nebulizer</deviceName>
    <manufacturerName>B.Well Swiss AG</manufacturerName>
    <manufacturerSrn>CH-MF-000012588</manufacturerSrn>
    <authorisedRepresentativeName>Blue Broccoli GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000000233</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1101595</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:46:00.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970384254402</udiDi>
    <basicUdiDi>697038425OCZL</basicUdiDi>
    <tradeName>Oxygen Concentrator</tradeName>
    <deviceName>Oxygen Concentrator</deviceName>
    <manufacturerName>HONSUN (NANTONG) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009428</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ares6A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:44:04.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229251405</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>NEB 150 MINI</tradeName>
    <deviceName>Aerosoltherapy Nebulizer</deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>p957150-2</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:47:28.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023800</udiDi>
    <basicUdiDi>69454290CW001LZ</basicUdiDi>
    <tradeName>High Frequency Chest Wall Oscillator</tradeName>
    <deviceName>High Frequency Chest Wall Oscillator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PK6</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:56:56.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023831</udiDi>
    <basicUdiDi>69454290CW001LZ</basicUdiDi>
    <tradeName>High Frequency Chest Wall Oscillator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PQ6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:05.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023848</udiDi>
    <basicUdiDi>69454290CW001LZ</basicUdiDi>
    <tradeName>High Frequency Chest Wall Oscillator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PQ6A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:47.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023855</udiDi>
    <basicUdiDi>69454290CW001LZ</basicUdiDi>
    <tradeName>High Frequency Chest Wall Oscillator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PQ6B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:23.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023862</udiDi>
    <basicUdiDi>69454290CW001LZ</basicUdiDi>
    <tradeName>High Frequency Chest Wall Oscillator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PQ6C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:06.660Z</lastUpdated>
  </row>
</eudamedExport>