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<eudamedExport entity="devices">
  <row>
    <udiDi>00874750005482</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750005482</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113815</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:45.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005499</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750005499</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113816</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:45.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005505</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750005505</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113820</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:45.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005512</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750005512</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113821</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:45.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005529</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750005529</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113822</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:45.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005536</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750005536</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113823</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:45.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005543</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750005543</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113824</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:27:45.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817136025223</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00817136025223</tradeName>
    <deviceName>Oro-Nasal Mask</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113868</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:27:02.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730001135</udiDi>
    <basicUdiDi>038373BM263XF</basicUdiDi>
    <tradeName>Pediatric Mask - Small</tradeName>
    <deviceName>Silicone Face Mask</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS81110EU-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:45:04.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>00383730000763</udiDi>
    <basicUdiDi>038373BM262XD</basicUdiDi>
    <tradeName>LiteTouch</tradeName>
    <deviceName>LiteTouch Face Mask</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1083784</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:45:04.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>NBK-1</udiDi>
    <basicUdiDi>++G401NBKRG</basicUdiDi>
    <tradeName>Nebulizer Mask Set</tradeName>
    <deviceName>Nebulizer Mask Set</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>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBK-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:49:26.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>NBK5</udiDi>
    <basicUdiDi>B-NBK5</basicUdiDi>
    <tradeName>Nebulizer Mask Set</tradeName>
    <deviceName>Nebulizer Mask Set</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>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBK5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:31:02.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>NBK21</udiDi>
    <basicUdiDi>B-NBK21</basicUdiDi>
    <tradeName>Nebulizer Mask Set</tradeName>
    <deviceName>Nebulizer Mask Set</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>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBK21</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:31:02.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>NBK13</udiDi>
    <basicUdiDi>B-NBK13</basicUdiDi>
    <tradeName>Nebulizer Mask Set</tradeName>
    <deviceName>Nebulizer Mask Set</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>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBK13</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:31:02.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NBK-9XF</udiDi>
    <basicUdiDi>B-NBK-9XF</basicUdiDi>
    <tradeName>Nebulizer Mask Set</tradeName>
    <deviceName>Nebulizer Mask Set</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>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBK-9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:22:15.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NBK-1WX</udiDi>
    <basicUdiDi>B-NBK-1WX</basicUdiDi>
    <tradeName>Nebulizer Mask Set</tradeName>
    <deviceName>Nebulizer Mask Set</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>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBK-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:22:15.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NBK-17A6</udiDi>
    <basicUdiDi>B-NBK-17A6</basicUdiDi>
    <tradeName>Nebulizer Mask Set</tradeName>
    <deviceName>Nebulizer Mask Set</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>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBK-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:22:11.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MDD-BreathingMaskKZ</udiDi>
    <basicUdiDi>B-MDD-BreathingMaskKZ</basicUdiDi>
    <tradeName>LiMAx Atemmaske</tradeName>
    <deviceName>LiMAx breathing mask</deviceName>
    <manufacturerName>Humedics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005094</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:20.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-936900029995GS</udiDi>
    <basicUdiDi>B-936900029995GS</basicUdiDi>
    <tradeName>D-936900029995GS</tradeName>
    <deviceName>SureflO2 Flow Indicator Oxygen Mask</deviceName>
    <manufacturerName>SureflO2 Trading Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000045991</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF02-MA01</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:42.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8901117BMK0123FKH7</udiDi>
    <basicUdiDi>B-8901117BMK0123FKH7</basicUdiDi>
    <tradeName>Baby Mask</tradeName>
    <deviceName>Baby Mask</deviceName>
    <manufacturerName>Cipla Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000038939</manufacturerSrn>
    <authorisedRepresentativeName>Cipla Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000038918</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Not Applicable for Baby Mask</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:16.736Z</lastUpdated>
  </row>
</eudamedExport>