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<eudamedExport entity="devices">
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    <udiDi>04974234813919</udiDi>
    <basicUdiDi>B-04974234813919</basicUdiDi>
    <tradeName>Sagami Original 002 XL3</tradeName>
    <deviceName>Polyurethane condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:25:54.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234811328</udiDi>
    <basicUdiDi>B-04974234811328</basicUdiDi>
    <tradeName>Sagami Original 001-2</tradeName>
    <deviceName>Polyurethane Condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES622</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:25:54.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234619023</udiDi>
    <basicUdiDi>B-04974234619023</basicUdiDi>
    <tradeName>Sagami Original 002-2</tradeName>
    <deviceName>Polyurethane Condom</deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES522</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:25:52.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>04974234062010</udiDi>
    <basicUdiDi>B-04974234062010</basicUdiDi>
    <tradeName>Sagami Original 002-L2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sagami Manufacturers Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000039689</manufacturerSrn>
    <authorisedRepresentativeName>Sagami Europe SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038926</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UES492</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:51.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608125</udiDi>
    <basicUdiDi>B-04711182608125</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</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>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0522</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:47.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608118</udiDi>
    <basicUdiDi>B-04711182608118</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</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>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0520</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:43.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608101</udiDi>
    <basicUdiDi>B-04711182608101</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</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>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0518</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:42.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608095</udiDi>
    <basicUdiDi>B-04711182608095</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</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>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0516</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:41.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608088</udiDi>
    <basicUdiDi>B-04711182608088</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</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>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0514</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:40.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182608071</udiDi>
    <basicUdiDi>B-04711182608071</basicUdiDi>
    <tradeName>silicone 2-way Foley Cathrter</tradeName>
    <deviceName>silicone 2-way Foley Cathrter</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>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4833-0512</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:17:36.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182607166</udiDi>
    <basicUdiDi>B-04711182607166</basicUdiDi>
    <tradeName>URINARY CATHETER FIXATION STRAP</tradeName>
    <deviceName>URINARY CATHETER FIXATION STRAP</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>U0280</emdnCode>
    <emdnDescription>URETERAL CATHETERS AND STENTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1800-0002</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:16:54.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182607159</udiDi>
    <basicUdiDi>B-04711182607159</basicUdiDi>
    <tradeName>URINARY CATHETER FIXATION STRAP</tradeName>
    <deviceName>URINARY CATHETER FIXATION STRAP</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>U0280</emdnCode>
    <emdnDescription>URETERAL CATHETERS AND STENTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1800-0001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:16:54.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182607050</udiDi>
    <basicUdiDi>B-04711182607050</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon 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>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1821-0606</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:16:49.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937692</udiDi>
    <basicUdiDi>B-04710961937692</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>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:55.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937685</udiDi>
    <basicUdiDi>B-04710961937685</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>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:54.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937654</udiDi>
    <basicUdiDi>B-04710961937654</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>4890-8220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:53.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937647</udiDi>
    <basicUdiDi>B-04710961937647</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>2026-08-02T08:09:49.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937630</udiDi>
    <basicUdiDi>B-04710961937630</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>2026-08-02T08:09:49.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937623</udiDi>
    <basicUdiDi>B-04710961937623</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>2026-08-02T08:09:48.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937616</udiDi>
    <basicUdiDi>B-04710961937616</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>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:47.462Z</lastUpdated>
  </row>
</eudamedExport>