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<eudamedExport entity="devices">
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    <udiDi>05060413640762</udiDi>
    <basicUdiDi>506041364TF015W7</basicUdiDi>
    <tradeName>TraxGuard Tracheostomy and Laryngectomy Shower Protector</tradeName>
    <deviceName>TraxGuard Tracheostomy and Laryngectomy Shower Protector</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y093399</emdnCode>
    <emdnDescription>WASHING, BATHING AND SHOWERING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/400</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:31.742Z</lastUpdated>
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  <row>
    <udiDi>05060413640779</udiDi>
    <basicUdiDi>506041364TF011V1TR</basicUdiDi>
    <tradeName>Silicone Fixation Tape 2cm x 3m</tradeName>
    <deviceName>Silicone Fixation Tape</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H900299</emdnCode>
    <emdnDescription>TAPES, MEDICAL/SURGICAL - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST/20</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:15.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640687</udiDi>
    <basicUdiDi>506041364TF014W5</basicUdiDi>
    <tradeName>TraxGuard Tracheostomy and Laryngectomy Protector. Large White</tradeName>
    <deviceName>TraxGuard Tracheostomy and Laryngectomy Protector</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058002</emdnCode>
    <emdnDescription>TRACHEOSTOMY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/300</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:14.983Z</lastUpdated>
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    <udiDi>05060413640526</udiDi>
    <basicUdiDi>506041364TF006V1UB</basicUdiDi>
    <tradeName>05060413640526</tradeName>
    <deviceName>TraxGuard Tracheostomy Tube Holder</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</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>TH/100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:12.471Z</lastUpdated>
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  <row>
    <udiDi>05060413640465</udiDi>
    <basicUdiDi>506041364TF013W3</basicUdiDi>
    <tradeName>Tracheostomy Speaking Valve (White)</tradeName>
    <deviceName>Tracheostomy Speaking Valve</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</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>TSV/100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:11.668Z</lastUpdated>
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  <row>
    <udiDi>05060413640540</udiDi>
    <basicUdiDi>506041364TF005V1U6</basicUdiDi>
    <tradeName>Breeze Endotracheal Tube Holder -Standard</tradeName>
    <deviceName>Breeze Endotracheal Tube Holder</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</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>TFP/200</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:10.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640434</udiDi>
    <basicUdiDi>506041364TF004W2</basicUdiDi>
    <tradeName>Non Sterile Bite Guard</tradeName>
    <deviceName>Non Sterile Bite Guard</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG/100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:07.676Z</lastUpdated>
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  <row>
    <udiDi>05060413640120</udiDi>
    <basicUdiDi>506041364TF008WA</basicUdiDi>
    <tradeName>Tube Tidy Clips -White</tradeName>
    <deviceName>Tube Tidy Clips</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFP/800</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:06.882Z</lastUpdated>
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  <row>
    <udiDi>05060413640113</udiDi>
    <basicUdiDi>506041364TF007W8</basicUdiDi>
    <tradeName>Transducer Holder</tradeName>
    <deviceName>Transducer Holder</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9011</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL TRANSDUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFP/400</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:06.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640175</udiDi>
    <basicUdiDi>506041364TF001VU</basicUdiDi>
    <tradeName>Non Sterile Eye Shield -Clear (Universal)</tradeName>
    <deviceName>Non Sterile Eye Shield</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040306</emdnCode>
    <emdnDescription>OPHTHALMIC PROTECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES/500/C</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:05.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640106</udiDi>
    <basicUdiDi>506041364TF010VV</basicUdiDi>
    <tradeName>Voice Prosthesis Brush</tradeName>
    <deviceName>Voice Prosthesis Brush</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0799</emdnCode>
    <emdnDescription>PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB/50</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:04.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640069</udiDi>
    <basicUdiDi>506041364TF006W6</basicUdiDi>
    <tradeName>Tracheostomy Tube Holder -Paediatric</tradeName>
    <deviceName>Tracheostomy Tube Holder -Paediatric</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</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>TH/150</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:02.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640007</udiDi>
    <basicUdiDi>506041364TF009WC</basicUdiDi>
    <tradeName>Tracheostomy Tube Cleaning Swab Large</tradeName>
    <deviceName>Tracheostomy Tube Cleaning Swab</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</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>TCS/900</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:14:00.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640076</udiDi>
    <basicUdiDi>506041364TF012VZ</basicUdiDi>
    <tradeName>Purifoam Laryngectomy Filters</tradeName>
    <deviceName>Purifoam Laryngectomy Filters</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF/100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:13:58.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640038</udiDi>
    <basicUdiDi>506041364TF005W4</basicUdiDi>
    <tradeName>Endotracheal Tube Holder -Extra Long</tradeName>
    <deviceName>Endotracheal Tube Holder</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</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>TFP/201</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:13:57.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640717</udiDi>
    <basicUdiDi>506041364TF014W5</basicUdiDi>
    <tradeName>TraxGuard Tracheostomy and Laryngectomy Protector. Large Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058002</emdnCode>
    <emdnDescription>TRACHEOSTOMY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:50:21.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640694</udiDi>
    <basicUdiDi>506041364TF014W5</basicUdiDi>
    <tradeName>TraxGuard Tracheostomy and Laryngectomy Protector. Large Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058002</emdnCode>
    <emdnDescription>TRACHEOSTOMY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:50:02.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640700</udiDi>
    <basicUdiDi>506041364TF014W5</basicUdiDi>
    <tradeName>TraxGuard Tracheostomy and Laryngectomy Protector. Large Grey</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058002</emdnCode>
    <emdnDescription>TRACHEOSTOMY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:50:01.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640724</udiDi>
    <basicUdiDi>506041364TF014W5</basicUdiDi>
    <tradeName>TraxGuard Tracheostomy and Laryngectomy Protector. Small White</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058002</emdnCode>
    <emdnDescription>TRACHEOSTOMY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:54.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060413640731</udiDi>
    <basicUdiDi>506041364TF014W5</basicUdiDi>
    <tradeName>TraxGuard Tracheostomy and Laryngectomy Protector. Small Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058002</emdnCode>
    <emdnDescription>TRACHEOSTOMY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/351</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:53.954Z</lastUpdated>
  </row>
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