<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04250203213509</udiDi>
    <basicUdiDi>42502032PRI0054J</basicUdiDi>
    <tradeName>PRIMEDISTRIP® SENSITIVE OVAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200370</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:50.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221450</udiDi>
    <basicUdiDi>42502032PRI0064L</basicUdiDi>
    <tradeName>Primed Tracheo Seal®, oval für Erwachsene</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200237</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:36.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221467</udiDi>
    <basicUdiDi>42502032PRI0064L</basicUdiDi>
    <tradeName>Primed Tracheo Seal® PED, rund für Kinder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200238</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203221474</udiDi>
    <basicUdiDi>42502032PRI0064L</basicUdiDi>
    <tradeName>Primed Tracheo Seal® Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200239</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:35.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>14250105600060</udiDi>
    <basicUdiDi>42501056-2.1.1-V4</basicUdiDi>
    <tradeName>Tracheostomy Necktape Length: 355 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>40-0005-011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:27.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>14250105600077</udiDi>
    <basicUdiDi>42501056-2.1.1-V4</basicUdiDi>
    <tradeName>Tracheostomy Necktape Length: 525 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>40-0005-044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:27.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>14250105601609</udiDi>
    <basicUdiDi>42501056-2.1.11-MZ</basicUdiDi>
    <tradeName>Tracheostomy Necktape Length: 490 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40-0008-033</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:26.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>14250105601616</udiDi>
    <basicUdiDi>42501056-2.1.11-MZ</basicUdiDi>
    <tradeName>Tracheostomy Necktape Length: 590 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40-0008-044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:26.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>14250105601623</udiDi>
    <basicUdiDi>42501056-2.1.11-MZ</basicUdiDi>
    <tradeName>Tracheostomy Necktape Length: 400 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40-0066-033</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:26.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681737409070</udiDi>
    <basicUdiDi>868173740TKNSRN</basicUdiDi>
    <tradeName>HTS</tradeName>
    <deviceName>TRACHEOSTOMY TUBE HOLDER</deviceName>
    <manufacturerName>Hts Medikal Tıbbi Malzeme San. Tic.Ltd.Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000048100</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>HTSRP1012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:33:35.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052107111532</udiDi>
    <basicUdiDi>805210711SPAZZTRACHEOST5G</basicUdiDi>
    <tradeName>BRUSH</tradeName>
    <deviceName>SPAZZOLINO PULIZIA CANNULE TRACHEO</deviceName>
    <manufacturerName>AK MEDICAL S.R.L. UNIPERSONALE</manufacturerName>
    <manufacturerSrn>IT-MF-000011246</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CHTT-BR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:13:22.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033480009067</udiDi>
    <basicUdiDi>8033480R0105802K</basicUdiDi>
    <tradeName>INBRUSH</tradeName>
    <deviceName>SPAZZOLINO</deviceName>
    <manufacturerName>BIHOS S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028025</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>BSP10000P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:01:41.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791015366</udiDi>
    <basicUdiDi>7331791-LTU-0-000-0006-3S</basicUdiDi>
    <tradeName>Stoma Sizing Guide (50 pcs)</tradeName>
    <deviceName>Stoma sizing guide</deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>7135</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:06:43.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791012914</udiDi>
    <basicUdiDi>7331791-GEN-A-000-0005-EM</basicUdiDi>
    <tradeName>Freevent Neckband, one-piece, small</tradeName>
    <deviceName>Freevent Neckband</deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>1651</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:06:37.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791011412</udiDi>
    <basicUdiDi>7331791-GEN-A-000-0002-EC</basicUdiDi>
    <tradeName>Provox Swab Small</tradeName>
    <deviceName>Provox Swab</deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>8250</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:06:17.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791002687</udiDi>
    <basicUdiDi>7331791-LTU-A-000-0001-JT</basicUdiDi>
    <tradeName>Provox LaryClip</tradeName>
    <deviceName>Provox LaryClip</deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>7669</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:05:46.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791002670</udiDi>
    <basicUdiDi>7331791-GEN-A-000-0000-E6</basicUdiDi>
    <tradeName>Provox TubeHolder</tradeName>
    <deviceName>Provox TubeHolder</deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>7668</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:02:23.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791002656</udiDi>
    <basicUdiDi>7331791-GEN-A-000-0001-E9</basicUdiDi>
    <tradeName>Provox TubeBrush 8 mm</tradeName>
    <deviceName>Provox TubeBrush</deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>7660</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:02:22.231Z</lastUpdated>
  </row>
  <row>
    <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>
  </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>
</eudamedExport>