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    <basicUdiDi>08420711MINISPCJV</basicUdiDi>
    <tradeName>MiniSPC Button - Low Profile Suprapubic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC-1417-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:45:49.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842071150068</udiDi>
    <basicUdiDi>08420711MINISPCJV</basicUdiDi>
    <tradeName>MiniSPC Button - Low Profile Suprapubic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC-1420-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:45:48.514Z</lastUpdated>
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    <udiDi>00842071150082</udiDi>
    <basicUdiDi>08420711MINISPCJV</basicUdiDi>
    <tradeName>MiniSPC Button - Low Profile Suprapubic Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC-1423-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:45:47.262Z</lastUpdated>
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    <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>
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    <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>
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  <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>
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  <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>
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  <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>
  <row>
    <udiDi>04710961934202</udiDi>
    <basicUdiDi>B-04710961934202</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1890-8214</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:33.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934196</udiDi>
    <basicUdiDi>B-04710961934196</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1890-8212</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:28.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718657210018</udiDi>
    <basicUdiDi>871865721PVC-CBQ6</basicUdiDi>
    <tradeName>Curan Closed System</tradeName>
    <deviceName>Curan Closed System</deviceName>
    <manufacturerName>Curan Medical BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CB08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:47:21.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250488601039</udiDi>
    <basicUdiDi>42504886000001/02/162U</basicUdiDi>
    <tradeName>Suprapubisches Wechselset CH10</tradeName>
    <deviceName>Care Flow Suprapubisches Wechselbesteck</deviceName>
    <manufacturerName>GHC German Health Care GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000039935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01/02/16/10/03/GHC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:39:32.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842071150860</udiDi>
    <basicUdiDi>08420711MINISPCJV</basicUdiDi>
    <tradeName>MiniSPC Button - Low Profile Suprapubic Catheter</tradeName>
    <deviceName>MiniSPC Button</deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC-1840-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:41.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718657214085</udiDi>
    <basicUdiDi>871865721PVC-CBQ6</basicUdiDi>
    <tradeName>Curan Complete Compact System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Curan Medical BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T01:48:24.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718657214108</udiDi>
    <basicUdiDi>871865721PVC-CBQ6</basicUdiDi>
    <tradeName>Curan Complete Compact System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Curan Medical BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T01:48:24.511Z</lastUpdated>
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  <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>
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    <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>
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  <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>
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