<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959029644</udiDi>
    <basicUdiDi>B-00606959029644</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, INT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IN961TS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:11.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029637</udiDi>
    <basicUdiDi>B-00606959029637</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IN961HS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:09.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029620</udiDi>
    <basicUdiDi>B-00606959029620</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE 60 Series, INTL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IN961S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:07.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959015166</udiDi>
    <basicUdiDi>B-00606959015166</basicUdiDi>
    <tradeName>Whisper Swivel II Packaged</tradeName>
    <deviceName>Whisper Swivel II Packaged</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>332113</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:02.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959006652</udiDi>
    <basicUdiDi>B-00606959006652</basicUdiDi>
    <tradeName>System One, Heated Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SYS1HT15</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:12.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08721325387103</udiDi>
    <basicUdiDi>872132538710BHTHOCOQM</basicUdiDi>
    <tradeName>CPAP Hose Cover</tradeName>
    <deviceName>CPAP Hose Cover</deviceName>
    <manufacturerName>Dongguan Shengtu Industrial Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000049658</manufacturerSrn>
    <authorisedRepresentativeName>Bauer + Herzog B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000048359</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHTHOCO</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:14:42.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>08721325387059</udiDi>
    <basicUdiDi>8721325387BHTNEPAPK</basicUdiDi>
    <tradeName>CPAP Headgear Neck Pad</tradeName>
    <deviceName>CPAP Headgear Neck Pad</deviceName>
    <manufacturerName>Dongguan Shengtu Industrial Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000049658</manufacturerSrn>
    <authorisedRepresentativeName>Bauer + Herzog B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000048359</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHTNEPA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:14:41.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>08721325387042</udiDi>
    <basicUdiDi>8721325387BHTSTCOSN</basicUdiDi>
    <tradeName>CPAP Headgear Strap Covers</tradeName>
    <deviceName>CPAP Headgear Strap Covers</deviceName>
    <manufacturerName>Dongguan Shengtu Industrial Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000049658</manufacturerSrn>
    <authorisedRepresentativeName>Bauer + Herzog B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000048359</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHTSTCO</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:14:40.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>08721325387035</udiDi>
    <basicUdiDi>8721325387BHTNAMLPC</basicUdiDi>
    <tradeName>CPAP Nasal Mask Liners</tradeName>
    <deviceName>CPAP Nasal Mask Liners</deviceName>
    <manufacturerName>Dongguan Shengtu Industrial Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000049658</manufacturerSrn>
    <authorisedRepresentativeName>Bauer + Herzog B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000048359</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHTNAML</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:14:36.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>08721325387028</udiDi>
    <basicUdiDi>8721325387BHTFFMLND</basicUdiDi>
    <tradeName>CPAP Mask Liners</tradeName>
    <deviceName>CPAP Full Face Mask Liners</deviceName>
    <manufacturerName>Dongguan Shengtu Industrial Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000049658</manufacturerSrn>
    <authorisedRepresentativeName>Bauer + Herzog B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000048359</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHTFFML</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:14:35.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058323087958</udiDi>
    <basicUdiDi>80583230MONITORDGRJ</basicUdiDi>
    <tradeName>08058323087958</tradeName>
    <deviceName>GENERATORE DI FLUSSO CPAP</deviceName>
    <manufacturerName>Intersurgical SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000010729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>999-1371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:02:56.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057717250008</udiDi>
    <basicUdiDi>805771725BLUNOTTED2</basicUdiDi>
    <tradeName>Blunotte 2</tradeName>
    <deviceName>Blunotte 2</deviceName>
    <manufacturerName>SXT S.r.l. - Sistemi per Telemedicina</manufacturerName>
    <manufacturerSrn>IT-MF-000020871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCPA2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:48:03.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600648</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:44:12.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600655</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:44:11.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600662</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:54.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600679</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:53.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600686</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:52.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600693</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:50.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600709</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:49.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927116600716</udiDi>
    <basicUdiDi>69271166000010VKJ</basicUdiDi>
    <tradeName>Positive airway pressure device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Meditec Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000013521</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:36.460Z</lastUpdated>
  </row>
</eudamedExport>