<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959007499</udiDi>
    <basicUdiDi>B-00606959007499</basicUdiDi>
    <tradeName>AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Med, SU</tradeName>
    <deviceName>AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Med, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:35.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007482</udiDi>
    <basicUdiDi>B-00606959007482</basicUdiDi>
    <tradeName>AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Sm, SU</tradeName>
    <deviceName>AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Sm, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:31.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007383</udiDi>
    <basicUdiDi>B-00606959007383</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, w/CapStrap, Large, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, w/CapStrap, Large, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:30.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007376</udiDi>
    <basicUdiDi>B-00606959007376</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:29.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007369</udiDi>
    <basicUdiDi>B-00606959007369</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:29.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007321</udiDi>
    <basicUdiDi>B-00606959007321</basicUdiDi>
    <tradeName>A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap, Large, SU</tradeName>
    <deviceName>A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap, Large, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:25.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007314</udiDi>
    <basicUdiDi>B-00606959007314</basicUdiDi>
    <tradeName>A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SU</tradeName>
    <deviceName>A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:24.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007307</udiDi>
    <basicUdiDi>B-00606959007307</basicUdiDi>
    <tradeName>A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, Small, SU</tradeName>
    <deviceName>A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, Small, SU</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:23.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004603</udiDi>
    <basicUdiDi>B-00606959004603</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:22.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004597</udiDi>
    <basicUdiDi>B-00606959004597</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:17.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004580</udiDi>
    <basicUdiDi>B-00606959004580</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with CapStrap, Small, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with CapStrap, Small, Single Use</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:17.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004573</udiDi>
    <basicUdiDi>B-00606959004573</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Large, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Large, Single Use</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:16.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004566</udiDi>
    <basicUdiDi>B-00606959004566</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single Use</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:15.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004559</udiDi>
    <basicUdiDi>B-00606959004559</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, Single Use</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:11.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004160</udiDi>
    <basicUdiDi>B-00606959004160</basicUdiDi>
    <tradeName>L Performax Su W/Ee Leak 2 — Single</tradeName>
    <deviceName>L Performax Su W/Ee Leak 2 — Single</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1061620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:10.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959000889</udiDi>
    <basicUdiDi>B-00606959000889</basicUdiDi>
    <tradeName>Performax Mask With Se, Single Patient Use, Intl, Large</tradeName>
    <deviceName>Performax Mask With Se, Single Patient Use, Intl, Large</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1054999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:09.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959000858</udiDi>
    <basicUdiDi>B-00606959000858</basicUdiDi>
    <tradeName>Performax Mask, Single Patient Use, Ee, Intl, Small</tradeName>
    <deviceName>Performax Mask, Single Patient Use, Ee, Intl, Small</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1054966</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:09.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000873</udiDi>
    <basicUdiDi>B-30606959000873</basicUdiDi>
    <tradeName>S Performax Su Intl W/Se —10 Pack</tradeName>
    <deviceName>S Performax Su Intl W/Se —10 Pack</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052547</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:53:07.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5060924460000209X4U</udiDi>
    <basicUdiDi>B-5060924460000209X4U</basicUdiDi>
    <tradeName>D-5060924460000209X4U</tradeName>
    <deviceName>JFA CPR Resuscitation Shield</deviceName>
    <manufacturerName>JFA Medical Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000021252</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JF0979</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:34:50.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707480023257</udiDi>
    <basicUdiDi>570748030100803208R</basicUdiDi>
    <tradeName>Disposable Face Masks</tradeName>
    <deviceName>Ambu® Disposable Face Mask</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000252051</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:05:47.996Z</lastUpdated>
  </row>
</eudamedExport>