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    <tradeName>Silicone Nasal Epistaxis Balloon</tradeName>
    <deviceName>Silicone Nasal Epistaxis Balloon</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3101-0830</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:27:31.958Z</lastUpdated>
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    <udiDi>03665870000023</udiDi>
    <basicUdiDi>366587CAVITDX</basicUdiDi>
    <tradeName>CAVI-T</tradeName>
    <deviceName>CAVI-T</deviceName>
    <manufacturerName>Dianosic - SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000003648</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030201</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBA01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:23:49.216Z</lastUpdated>
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    <udiDi>04711182605476</udiDi>
    <basicUdiDi>471096193111201FG</basicUdiDi>
    <tradeName>Silicone Nasal Epistaxis Balloon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3102-2010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T07:37:53.463Z</lastUpdated>
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    <udiDi>04711182605483</udiDi>
    <basicUdiDi>471096193111201FG</basicUdiDi>
    <tradeName>Silicone Nasal Epistaxis Balloon</tradeName>
    <deviceName></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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3103-0930</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-25T07:37:53.370Z</lastUpdated>
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    <udiDi>00385640000314</udiDi>
    <basicUdiDi>03856490305_EPISTAXI8S</basicUdiDi>
    <tradeName>Epistax Balloon Catheter</tradeName>
    <deviceName>Epistax Balloon Catheter</deviceName>
    <manufacturerName>Summit Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000026771</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-4200-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:45:13.960Z</lastUpdated>
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  <row>
    <udiDi>14711182605480</udiDi>
    <basicUdiDi>B-14711182605480</basicUdiDi>
    <tradeName>Silicone Nasal Epistaxis Balloon</tradeName>
    <deviceName>Silicone Nasal Epistaxis Balloon</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3103-0930</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:29.724Z</lastUpdated>
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    <udiDi>14711182605473</udiDi>
    <basicUdiDi>B-14711182605473</basicUdiDi>
    <tradeName>Silicone Nasal Epistaxis Balloon</tradeName>
    <deviceName>Silicone Nasal Epistaxis Balloon</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3102-2010</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:28.917Z</lastUpdated>
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    <udiDi>14711182605466</udiDi>
    <basicUdiDi>B-14711182605466</basicUdiDi>
    <tradeName>Silicone Nasal Epistaxis Balloon</tradeName>
    <deviceName>Silicone Nasal Epistaxis Balloon</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3101-0830</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:28.117Z</lastUpdated>
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    <udiDi>08906039319408</udiDi>
    <basicUdiDi>B-08906039319408</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Intra-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E31030</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:13:24.046Z</lastUpdated>
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    <udiDi>08906039319392</udiDi>
    <basicUdiDi>B-08906039319392</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Double Balloon)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E31031</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:13:23.222Z</lastUpdated>
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    <udiDi>08906039319385</udiDi>
    <basicUdiDi>B-08906039319385</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Post-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E31010</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:13:19.266Z</lastUpdated>
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    <udiDi>08906039312454</udiDi>
    <basicUdiDi>B-08906039312454</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Intra-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E31030</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:02:09.063Z</lastUpdated>
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    <udiDi>08906039312447</udiDi>
    <basicUdiDi>B-08906039312447</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Double Balloon)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E31031</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:02:08.263Z</lastUpdated>
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    <udiDi>08906039312430</udiDi>
    <basicUdiDi>B-08906039312430</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Post-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E31010</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:02:07.483Z</lastUpdated>
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    <udiDi>08904428705009</udiDi>
    <basicUdiDi>B-08904428705009</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Post-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F31010</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:15:37.970Z</lastUpdated>
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    <udiDi>08904428704996</udiDi>
    <basicUdiDi>B-08904428704996</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Double Balloon)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F31031</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:15:37.169Z</lastUpdated>
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    <udiDi>08904428704989</udiDi>
    <basicUdiDi>B-08904428704989</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Intra-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F31030</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:15:36.370Z</lastUpdated>
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    <basicUdiDi>B-08904428701247</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Intra-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F31030</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:13:19.367Z</lastUpdated>
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    <basicUdiDi>B-08904428701230</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Double Balloon)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F31031</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:13:17.761Z</lastUpdated>
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    <udiDi>08904428701223</udiDi>
    <basicUdiDi>B-08904428701223</basicUdiDi>
    <tradeName>Orleon</tradeName>
    <deviceName>Epistaxis Balloon Catheter (Post-Pack)</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>MDD</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F31010</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:13:15.366Z</lastUpdated>
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