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    <manufacturerName>REDA Instrumente GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <reference>R070-000060-001</reference>
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    <lastUpdated>2026-07-18T22:07:11.316Z</lastUpdated>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <reference>R070-000060-301</reference>
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    <lastUpdated>2026-07-18T22:07:10.564Z</lastUpdated>
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    <tradeName>Navina Tube Set</tradeName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:35:33.065Z</lastUpdated>
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    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
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    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900911</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:35:29.521Z</lastUpdated>
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    <udiDi>07333387028118</udiDi>
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    <tradeName>Navina Accessories</tradeName>
    <deviceName>Navina, Bowel Management System Accessories</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6901200</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:31.911Z</lastUpdated>
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    <udiDi>07333387027890</udiDi>
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    <tradeName>Navina Tube Set</tradeName>
    <deviceName>Navina, Bowel Management System</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6901100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:26.308Z</lastUpdated>
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    <tradeName>Navina Smart System Regular</tradeName>
    <deviceName>Navina, Bowel Management System</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900910</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:25.521Z</lastUpdated>
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    <tradeName>Qora</tradeName>
    <deviceName>Qora Stool Management Kit</deviceName>
    <manufacturerName>QNQ Design and Development Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000044442</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EFMG-22014-002</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:58:39.075Z</lastUpdated>
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    <udiDi>M294CM1709220</udiDi>
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    <tradeName>Silicone transfer tube w/ Toomey syringe adaptor w/ "C" clamp</tradeName>
    <deviceName>Silicone transfer tube w/ Toomey syringe adaptor w/ "C" clamp</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020399</emdnCode>
    <emdnDescription>EVACUATION TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM170922</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:47:05.797Z</lastUpdated>
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    <udiDi>M294CM1709210</udiDi>
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    <deviceName>Silicone transfer tube w/ 1-way stopcock</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020399</emdnCode>
    <emdnDescription>EVACUATION TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM170921</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:47:04.996Z</lastUpdated>
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    <udiDi>M294CM1709200</udiDi>
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    <tradeName>Double ended silicone transfer tube w/ Fe/Male luer adaptors &amp; "C" clamp; 15cm/ 6"</tradeName>
    <deviceName>Double ended silicone transfer tube w/ Fe/Male luer adaptors &amp; "C" clamp; 15cm/ 6"</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020399</emdnCode>
    <emdnDescription>EVACUATION TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM170920</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:47:03.398Z</lastUpdated>
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    <udiDi>B293HFT110E0</udiDi>
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    <tradeName>B293HFT110E0</tradeName>
    <deviceName>High Flow Tubing</deviceName>
    <manufacturerName>MIVI Neuroscience</manufacturerName>
    <manufacturerSrn>US-MF-000020746</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020399</emdnCode>
    <emdnDescription>EVACUATION TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HFT-110-E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:24.481Z</lastUpdated>
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    <udiDi>07333387027265</udiDi>
    <basicUdiDi>733338724105D5</basicUdiDi>
    <tradeName>Navina Smart System Regular</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900912</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:17:27.952Z</lastUpdated>
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    <udiDi>07333387027326</udiDi>
    <basicUdiDi>733338724105D5</basicUdiDi>
    <tradeName>Navina Smart System Regular</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900930</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:17:27.926Z</lastUpdated>
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    <udiDi>07333387027388</udiDi>
    <basicUdiDi>733338724105D5</basicUdiDi>
    <tradeName>Navina Smart System Regular</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900945</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:17:27.909Z</lastUpdated>
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    <udiDi>07333387027470</udiDi>
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    <tradeName>Navina Smart System Regular</tradeName>
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    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
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    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900970</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:17:27.878Z</lastUpdated>
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    <tradeName>Navina Smart System Regular</tradeName>
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    <manufacturerName>Wellspect HealthCare</manufacturerName>
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    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6900980</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:17:27.846Z</lastUpdated>
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    <udiDi>07333387027951</udiDi>
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    <tradeName>Navina Tube Set</tradeName>
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    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
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    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6901130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:17:27.726Z</lastUpdated>
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    <tradeName>Navina Tube Set</tradeName>
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    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6901170</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>Navina Tube Set</tradeName>
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    <manufacturerName>Wellspect HealthCare</manufacturerName>
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    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6901180</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:17:27.688Z</lastUpdated>
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