<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04250203275026</udiDi>
    <basicUdiDi>42502032PRI0785D</basicUdiDi>
    <tradeName>Microguard VoiceHMEF</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>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:00.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>16933298299607</udiDi>
    <basicUdiDi>69332982077W5</basicUdiDi>
    <tradeName>16933298299607</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:44:21.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>16933298299614</udiDi>
    <basicUdiDi>69332982077W5</basicUdiDi>
    <tradeName>16933298299614</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:44:21.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>16933298299621</udiDi>
    <basicUdiDi>69332982077W5</basicUdiDi>
    <tradeName>16933298299621</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:44:21.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737103936</udiDi>
    <basicUdiDi>0841737102021UN</basicUdiDi>
    <tradeName>00841737103936</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AAA-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:29:16.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737103998</udiDi>
    <basicUdiDi>0841737102021UN</basicUdiDi>
    <tradeName>00841737103998</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVT-DPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:29:16.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737104001</udiDi>
    <basicUdiDi>0841737102021UN</basicUdiDi>
    <tradeName>00841737104001</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVT-ADPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:29:16.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737105466</udiDi>
    <basicUdiDi>0841737102021UN</basicUdiDi>
    <tradeName>00841737105466</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVT-UKIT-GB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:29:16.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737105473</udiDi>
    <basicUdiDi>0841737102021UN</basicUdiDi>
    <tradeName>00841737105473</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVT-UKIT-NIST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:29:16.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737105565</udiDi>
    <basicUdiDi>0841737102021UN</basicUdiDi>
    <tradeName>00841737105565</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPF-TA-22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:29:16.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841737105640</udiDi>
    <basicUdiDi>0841737102021UN</basicUdiDi>
    <tradeName>00841737105640</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVT-UKIT-DE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:29:16.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904428744961</udiDi>
    <basicUdiDi>89044287BRS4P</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EA91072</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:53:55.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>26933298299604</udiDi>
    <basicUdiDi>69332982077W5</basicUdiDi>
    <tradeName>26933298299604</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:02.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>26933298299611</udiDi>
    <basicUdiDi>69332982077W5</basicUdiDi>
    <tradeName>26933298299611</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:02.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>26933298299628</udiDi>
    <basicUdiDi>69332982077W5</basicUdiDi>
    <tradeName>26933298299628</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:02.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002217</udiDi>
    <basicUdiDi>08482530SPEAKFREEGJ</basicUdiDi>
    <tradeName>SpeakFree HME EasyFlow, 30 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 1090EF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002279</udiDi>
    <basicUdiDi>08482530SPEAKFREEGJ</basicUdiDi>
    <tradeName>SpeakFree HME ClassicFlow, 6 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 1090EZ-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002286</udiDi>
    <basicUdiDi>08482530SPEAKFREEGJ</basicUdiDi>
    <tradeName>SpeakFree HME EasyFlow, 6 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 1090EF-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002293</udiDi>
    <basicUdiDi>08482530DAY&amp;NIGHTVZ</basicUdiDi>
    <tradeName>Blom-Singer Day&amp;Night EasyFlow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 1092</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253002316</udiDi>
    <basicUdiDi>08482530DAY&amp;NIGHTVZ</basicUdiDi>
    <tradeName>Blom-Singer Day&amp;Night ClassicFlow, 10 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BE 1091-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:59.354Z</lastUpdated>
  </row>
</eudamedExport>