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<eudamedExport entity="devices">
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    <tradeName>Kaniula wewnętrzna</tradeName>
    <deviceName>Tracheostomijna kaniula wewnętrzna</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>45-5000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:37.321Z</lastUpdated>
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    <udiDi>05901292107901</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>33-3010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:36.788Z</lastUpdated>
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    <udiDi>05901292107369</udiDi>
    <basicUdiDi>59012921RTZMSY</basicUdiDi>
    <tradeName>Rurka tracheostomijna z mankietem</tradeName>
    <deviceName>Rurka tracheostomijna z mankietem</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31-3010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:36.761Z</lastUpdated>
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    <udiDi>05901292105396</udiDi>
    <basicUdiDi>59012921RDTPQ4</basicUdiDi>
    <tradeName>Rurka dooskrzelowa prawostronna, tracheostomijna</tradeName>
    <deviceName>Rurka dooskrzelowa prawostronna, tracheostomijna</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040103</emdnCode>
    <emdnDescription>ENDOBRONCHIAL TUBES, RIGHT, TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22-3770</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:36.174Z</lastUpdated>
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    <udiDi>05901292104924</udiDi>
    <basicUdiDi>59012921RDPXB</basicUdiDi>
    <tradeName>Rurka dooskrzelowa prawostronna</tradeName>
    <deviceName>Rurka dooskrzelowa prawostronna</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040102</emdnCode>
    <emdnDescription>ENDOBRONCHIAL OROPHARYNGEAL TUBES, RIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22-2410</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:31.695Z</lastUpdated>
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  <row>
    <udiDi>05901292104467</udiDi>
    <basicUdiDi>59012921RDTLPU</basicUdiDi>
    <tradeName>Rurka dooskrzelowa lewostronna, tracheostomijna</tradeName>
    <deviceName>Rurka dooskrzelowa lewostronna, tracheostomijna</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040203</emdnCode>
    <emdnDescription>ENDOBRONCHIAL TUBES, LEFT, TRACHEOSTOMY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-3770</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:29.312Z</lastUpdated>
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    <udiDi>05901292104177</udiDi>
    <basicUdiDi>59012921RDLX3</basicUdiDi>
    <tradeName>Rurka dooskrzelowa lewostronna</tradeName>
    <deviceName>Rurka dooskrzelowa lewostronna</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040202</emdnCode>
    <emdnDescription>ENDOBRONCHIAL OROPHARYNGEAL TUBES, LEFT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-2410</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:27.703Z</lastUpdated>
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  <row>
    <udiDi>05901292104061</udiDi>
    <basicUdiDi>59012921RDAKMZ</basicUdiDi>
    <tradeName>Zestaw złączy do rurki dooskrzelowej</tradeName>
    <deviceName>Zestaw złączy do rurki dooskrzelowej</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010480</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19-0100</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:26.897Z</lastUpdated>
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  <row>
    <udiDi>05901292101039</udiDi>
    <basicUdiDi>59012921RIBMNZ</basicUdiDi>
    <tradeName>Rurka intubacyjna bez mankietu</tradeName>
    <deviceName>Rurka intubacyjna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01030101</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFLESS, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04-2010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:23.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292100377</udiDi>
    <basicUdiDi>59012921RIZMR9</basicUdiDi>
    <tradeName>Rurka intubacyjna z mankietem</tradeName>
    <deviceName>Rurka intubacyjna z mankietem</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01030201</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-3010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:22.904Z</lastUpdated>
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  <row>
    <udiDi>05060417204137</udiDi>
    <basicUdiDi>506041720PHONIQHMEF-SUUK</basicUdiDi>
    <tradeName>05060417204137</tradeName>
    <deviceName>PHONIQ DIGICLOSE HME FILTER PHONIQ LOW PROFILE HME FILTER</deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAPFT0001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:44:47.337Z</lastUpdated>
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    <udiDi>05060417203871</udiDi>
    <basicUdiDi>506041720PROTECTOR-SU53</basicUdiDi>
    <tradeName>05060417203871</tradeName>
    <deviceName>TRACHEOSTOMA PROTECTIVE FILTERS BUCHANAN BUCHANAN LITE BUCHANAN DELTANEX LARYNGOFOAM</deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LALFF0003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:44:44.941Z</lastUpdated>
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    <udiDi>05060031485547</udiDi>
    <basicUdiDi>506003148TracheoSwabVB</basicUdiDi>
    <tradeName>Tracheosotomy Cleaning Swabs 7mm</tradeName>
    <deviceName>Tracheosotomy Cleaning Swabs 7mm</deviceName>
    <manufacturerName>Brightwake Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012039</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR4558</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:25:05.682Z</lastUpdated>
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    <udiDi>05060031483208</udiDi>
    <basicUdiDi>506003148VoiceProBrushKA</basicUdiDi>
    <tradeName>Voice Prosthesis Brushes</tradeName>
    <deviceName>Voice Prosthesis Brushes</deviceName>
    <manufacturerName>Brightwake Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012039</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR4508</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:24:59.277Z</lastUpdated>
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    <udiDi>05060031483123</udiDi>
    <basicUdiDi>506003148TracheoNeckS6</basicUdiDi>
    <tradeName>Tracheostomy Tube Holder Adult</tradeName>
    <deviceName>Tracheostomy Neck Band</deviceName>
    <manufacturerName>Brightwake Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012039</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR4512</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:24:55.269Z</lastUpdated>
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    <udiDi>05060031483000</udiDi>
    <basicUdiDi>506003148EndoTubeHolCQ</basicUdiDi>
    <tradeName>Endotracheal Tube Holder</tradeName>
    <deviceName>Endotracheal Tube Holder</deviceName>
    <manufacturerName>Brightwake Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012039</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01038099</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR4509</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:24:54.495Z</lastUpdated>
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    <udiDi>05060031470475</udiDi>
    <basicUdiDi>506003147Sofshield9K</basicUdiDi>
    <tradeName>Sofshield Laryngectomy Protector</tradeName>
    <deviceName>Sofshield Laryngectomy Protector</deviceName>
    <manufacturerName>Brightwake Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012039</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS3669</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:24:47.273Z</lastUpdated>
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    <udiDi>05055788782490</udiDi>
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    <tradeName>05055788782490</tradeName>
    <deviceName>Video Display Accessories</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01038099</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>038-990-011U</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:17:57.338Z</lastUpdated>
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    <basicUdiDi>5055788700031B01JV</basicUdiDi>
    <tradeName>05055788732495</tradeName>
    <deviceName>ET Tube Holder</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01038099</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>038-96-001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:17:55.754Z</lastUpdated>
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    <basicUdiDi>5055788700031C01K2</basicUdiDi>
    <tradeName>Magill Forceps</tradeName>
    <deviceName>Forceps</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01038099</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>042-413</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:17:54.165Z</lastUpdated>
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