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    <basicUdiDi>4060139000042H</basicUdiDi>
    <tradeName>04060139050013</tradeName>
    <deviceName>Miniflow</deviceName>
    <manufacturerName>medin Medical Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006975</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM4000SLE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:05:22.030Z</lastUpdated>
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    <udiDi>04060139050006</udiDi>
    <basicUdiDi>4060139000122G</basicUdiDi>
    <tradeName>04060139050006</tradeName>
    <deviceName>Miniflow procedure pack</deviceName>
    <manufacturerName>medin Medical Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM4000/10SLE</reference>
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    <lastUpdated>2026-07-30T20:05:21.230Z</lastUpdated>
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    <udiDi>07898966741357</udiDi>
    <basicUdiDi>5060127400005NS</basicUdiDi>
    <tradeName>Shaker Deluxe Light Resistance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>POWERbreathe International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045438</manufacturerSrn>
    <authorisedRepresentativeName>HaB GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041460</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBSDLR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:26.873Z</lastUpdated>
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    <udiDi>07898966741333</udiDi>
    <basicUdiDi>5060127400005NS</basicUdiDi>
    <tradeName>Shaker Deluxe Kids</tradeName>
    <deviceName></deviceName>
    <manufacturerName>POWERbreathe International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045438</manufacturerSrn>
    <authorisedRepresentativeName>HaB GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041460</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBSDK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:26.248Z</lastUpdated>
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    <udiDi>07898966741364</udiDi>
    <basicUdiDi>5060127400005NS</basicUdiDi>
    <tradeName>Shaker Medic Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>POWERbreathe International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045438</manufacturerSrn>
    <authorisedRepresentativeName>HaB GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041460</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBSP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:25.340Z</lastUpdated>
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    <udiDi>07898966741227</udiDi>
    <basicUdiDi>5060127400005NS</basicUdiDi>
    <tradeName>Shaker Classic</tradeName>
    <deviceName>POWERbreathe Shaker</deviceName>
    <manufacturerName>POWERbreathe International Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045438</manufacturerSrn>
    <authorisedRepresentativeName>HaB GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041460</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBSC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:16.156Z</lastUpdated>
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  <row>
    <udiDi>04036616000451</udiDi>
    <basicUdiDi>4036616OOM109MZ</basicUdiDi>
    <tradeName>OOM109</tradeName>
    <deviceName>Sauertsoffsensoren</deviceName>
    <manufacturerName>Honeywell Healthcare Solutions GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9080</emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E01-00-0085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:28:44.845Z</lastUpdated>
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  <row>
    <udiDi>04036616000345</udiDi>
    <basicUdiDi>4036616OOMCK</basicUdiDi>
    <tradeName>OOM101</tradeName>
    <deviceName>Sauerstoffsensoren</deviceName>
    <manufacturerName>Honeywell Healthcare Solutions GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004924</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9080</emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-00-0013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:28:44.050Z</lastUpdated>
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  <row>
    <udiDi>03701510101719</udiDi>
    <basicUdiDi>370151010037ZS</basicUdiDi>
    <tradeName>03701510101719</tradeName>
    <deviceName>INHALATEUR COOPER</deviceName>
    <manufacturerName>Coopération pharmaceutique française</manufacturerName>
    <manufacturerSrn>FR-MF-000002412</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R900901</emdnCode>
    <emdnDescription>INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200865</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:42:04.914Z</lastUpdated>
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    <udiDi>03666256011282</udiDi>
    <basicUdiDi>3666256DI100A00VENU0802WR</basicUdiDi>
    <tradeName>Embout nasal 22M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Int'Air Médical</manufacturerName>
    <manufacturerSrn>FR-MF-000000328</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9080</emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC59</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:29:31.550Z</lastUpdated>
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  <row>
    <udiDi>03666256010988</udiDi>
    <basicUdiDi>3666256DI100AP0VENU0802SX</basicUdiDi>
    <tradeName>Embout buccal 22M/15F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Int'Air Médical</manufacturerName>
    <manufacturerSrn>FR-MF-000000328</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC26</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:29:30.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>20859760005145</udiDi>
    <basicUdiDi>0859760005PMV2001J6</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™)</tradeName>
    <deviceName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:26.792Z</lastUpdated>
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  <row>
    <udiDi>20859760005084</udiDi>
    <basicUdiDi>0859760005PMA2000AV</basicUdiDi>
    <tradeName>Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000)</tradeName>
    <deviceName>Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R900680</emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMA 2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:25.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>20859760005060</udiDi>
    <basicUdiDi>0859760005PMV2000J4</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear)</tradeName>
    <deviceName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:25.187Z</lastUpdated>
  </row>
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    <udiDi>20859760005039</udiDi>
    <basicUdiDi>0859760005PMV2020JA</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear)</tradeName>
    <deviceName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2020</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:21.187Z</lastUpdated>
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    <udiDi>20859760005022</udiDi>
    <basicUdiDi>0859760005PMV007AS</basicUdiDi>
    <tradeName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (Aqua Color™)</tradeName>
    <deviceName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (Aqua Color™)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:20.392Z</lastUpdated>
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    <udiDi>20859760005015</udiDi>
    <basicUdiDi>0859760005PMV005AN</basicUdiDi>
    <tradeName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white)</tradeName>
    <deviceName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 005</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:19.588Z</lastUpdated>
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    <udiDi>00874750007998</udiDi>
    <basicUdiDi>081713602691184BU</basicUdiDi>
    <tradeName>00874750007998</tradeName>
    <deviceName>Volume Calibration Syringe</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:05:29.925Z</lastUpdated>
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    <udiDi>00810020360028</udiDi>
    <basicUdiDi>08401069MESeriesJA</basicUdiDi>
    <tradeName>00810020360028</tradeName>
    <deviceName>Nafion™ Tube Dryer, ME Series</deviceName>
    <manufacturerName>Perma Pure, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003962</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9080</emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-050-03-243</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:57:21.922Z</lastUpdated>
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    <udiDi>00810020360004</udiDi>
    <basicUdiDi>08401069MESeriesJA</basicUdiDi>
    <tradeName>ME-050-03-46 ME Dryer</tradeName>
    <deviceName>Nafion™ Tube Dryer, ME Series</deviceName>
    <manufacturerName>Perma Pure, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003962</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9080</emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-050-03-46</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:55:52.349Z</lastUpdated>
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