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<eudamedExport entity="devices">
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    <udiDi>04710961930990</udiDi>
    <basicUdiDi>B-04710961930990</basicUdiDi>
    <tradeName>Slllcone Tracheostomy Tube, Ordinary Cuff</tradeName>
    <deviceName>Slllcone Tracheostomy Tube, Ordinary Cuff</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1560-0080</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:04.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930983</udiDi>
    <basicUdiDi>B-04710961930983</basicUdiDi>
    <tradeName>Slllcone Tracheostomy Tube, Ordinary Cuff</tradeName>
    <deviceName>Slllcone Tracheostomy Tube, Ordinary Cuff</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1560-0070</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:03.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930914</udiDi>
    <basicUdiDi>B-04710961930914</basicUdiDi>
    <tradeName>Sillcone Endotracheal Tube</tradeName>
    <deviceName>Sillcone Endotracheal Tube</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R01030202</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1555-0080</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:02:00.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930907</udiDi>
    <basicUdiDi>B-04710961930907</basicUdiDi>
    <tradeName>Sillcone Endotracheal Tube</tradeName>
    <deviceName>Sillcone Endotracheal Tube</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R01030202</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1555-0075</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:01:58.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961930891</udiDi>
    <basicUdiDi>B-04710961930891</basicUdiDi>
    <tradeName>Sillcone Endotracheal Tube</tradeName>
    <deviceName>Sillcone Endotracheal Tube</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R01030202</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1555-0070</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:01:57.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160150</udiDi>
    <basicUdiDi>697551916NOCV8</basicUdiDi>
    <tradeName>Disposable Nasal Oxygen Cannula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Adult-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:05:31.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519160160</udiDi>
    <basicUdiDi>697551916NOCV8</basicUdiDi>
    <tradeName>06975519160160</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Infant-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:05:27.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160174</udiDi>
    <basicUdiDi>697551916NOCV8</basicUdiDi>
    <tradeName>Disposable Nasal Oxygen Cannula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Adult-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:05:26.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250307611355</udiDi>
    <basicUdiDi>42503076IZE0709B</basicUdiDi>
    <tradeName>ALM Tube I.D. 8.0, O.D. 11.0</tradeName>
    <deviceName>ALM Tube I.D. 6.0, O.D. 8.2</deviceName>
    <manufacturerName>inomed Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005589</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>520847</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T10:59:29.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250307611362</udiDi>
    <basicUdiDi>42503076IZE0709B</basicUdiDi>
    <tradeName>ALM Tube I.D. 7.5, O.D. 10.3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>inomed Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01030201</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>520846</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T10:59:29.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250307611911</udiDi>
    <basicUdiDi>42503076IZE0709B</basicUdiDi>
    <tradeName>ALM Tube, ID 6.0, OD 8.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>inomed Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R01030201</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>520843</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T10:59:08.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060274504234</udiDi>
    <basicUdiDi>50602745000667</basicUdiDi>
    <tradeName>Firesafe Cannula Valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BPR Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000003347</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010280</emdnCode>
    <emdnDescription>OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>827-2001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T10:39:18.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058521</udiDi>
    <basicUdiDi>B-00606959058521</basicUdiDi>
    <tradeName>A40 Pro/EFL, SysOne Htd Tube Hum, Nordic</tradeName>
    <deviceName>A40 Pro/EFL, SysOne Htd Tube Hum, Nordic</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:58:19.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959057920</udiDi>
    <basicUdiDi>B-00606959057920</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, France</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, France</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:58:17.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959041028</udiDi>
    <basicUdiDi>B-00606959041028</basicUdiDi>
    <tradeName>A Series System One Heated Humidifier, JP</tradeName>
    <deviceName>A Series System One Heated Humidifier, JP</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1111553</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:55.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039650</udiDi>
    <basicUdiDi>B-00606959039650</basicUdiDi>
    <tradeName>Silver Series Heated Tube Humidifier</tradeName>
    <deviceName>Silver Series Heated Tube Humidifier</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1120349</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:53.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959027596</udiDi>
    <basicUdiDi>B-00606959027596</basicUdiDi>
    <tradeName>DreamStation Humidifier TR</tradeName>
    <deviceName>DreamStation Humidifier TR</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:52.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959027299</udiDi>
    <basicUdiDi>B-00606959027299</basicUdiDi>
    <tradeName>DreamStation Humidifier IT</tradeName>
    <deviceName>DreamStation Humidifier IT</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:49.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021600</udiDi>
    <basicUdiDi>B-00606959021600</basicUdiDi>
    <tradeName>Patient Circuit, CA Infant</tradeName>
    <deviceName>Patient Circuit, CA Infant</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325-9237</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:47.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021563</udiDi>
    <basicUdiDi>B-00606959021563</basicUdiDi>
    <tradeName>A Series System One Heated Tube Humidifier, INTL</tradeName>
    <deviceName>A Series System One Heated Tube Humidifier, INTL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1111555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:57:45.842Z</lastUpdated>
  </row>
</eudamedExport>