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    <basicUdiDi>B-18698703339023</basicUdiDi>
    <tradeName>KATHYDOR</tradeName>
    <deviceName>HYDROTOUCH Sterile Water Soluble Lubricating Gel - 6mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYT-006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:30:06.053Z</lastUpdated>
  </row>
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    <udiDi>18698703333991</udiDi>
    <basicUdiDi>B-18698703333991</basicUdiDi>
    <tradeName>UROLUBE</tradeName>
    <deviceName>UROLUBE - Sterile Lubricant Gel With Lidocaine (CHG Free), 11mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UL-L 011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:30:05.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>18698703333984</udiDi>
    <basicUdiDi>B-18698703333984</basicUdiDi>
    <tradeName>UROLUBE</tradeName>
    <deviceName>UROLUBE - Sterile Lubricant Gel With Lidocaine (CHG Free), 6mL</deviceName>
    <manufacturerName>İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000017811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UL-L 006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:30:04.456Z</lastUpdated>
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    <udiDi>14711182612723</udiDi>
    <basicUdiDi>B-14711182612723</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4880-0212</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:22:24.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182612716</udiDi>
    <basicUdiDi>B-14711182612716</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4880-0214</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:22:20.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182612709</udiDi>
    <basicUdiDi>B-14711182612709</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4880-0216</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:22:19.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937699</udiDi>
    <basicUdiDi>B-14710961937699</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Puncture Set</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter Puncture Set</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>U040101</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-9214</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:05.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937682</udiDi>
    <basicUdiDi>B-14710961937682</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Puncture Set</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter Puncture Set</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>U040101</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-9212</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:03.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937651</udiDi>
    <basicUdiDi>B-14710961937651</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:01.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937644</udiDi>
    <basicUdiDi>B-14710961937644</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8218</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:00.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937637</udiDi>
    <basicUdiDi>B-14710961937637</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8216</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:59.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937620</udiDi>
    <basicUdiDi>B-14710961937620</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8214</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:56.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937613</udiDi>
    <basicUdiDi>B-14710961937613</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8212</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:54.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937606</udiDi>
    <basicUdiDi>B-14710961937606</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-0224</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:53.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937590</udiDi>
    <basicUdiDi>B-14710961937590</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-0222</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:52.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937569</udiDi>
    <basicUdiDi>B-14710961937569</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-0216</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:49.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937583</udiDi>
    <basicUdiDi>B-14710961937583</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-0220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:47.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937576</udiDi>
    <basicUdiDi>B-14710961937576</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-0218</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:46.494Z</lastUpdated>
  </row>
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    <udiDi>14710961937552</udiDi>
    <basicUdiDi>B-14710961937552</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-0214</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:29.446Z</lastUpdated>
  </row>
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    <udiDi>14710961937545</udiDi>
    <basicUdiDi>B-14710961937545</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</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>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-0212</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:15:28.644Z</lastUpdated>
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</eudamedExport>