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<eudamedExport entity="devices">
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    <tradeName>Prism0cal</tradeName>
    <deviceName>Prism0cal</deviceName>
    <manufacturerName>Bieffe Medital S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019172</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9099</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>112958</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:12:05.195Z</lastUpdated>
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    <udiDi>86989077478328</udiDi>
    <basicUdiDi>B-86989077478328</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Hemodialysis catheter kit</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900201</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - HCT10029</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:35:32.198Z</lastUpdated>
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    <basicUdiDi>7332414VA0000232T</basicUdiDi>
    <tradeName>U9000 Plus Ultrafilter</tradeName>
    <deviceName>U9000 Plus Ultrafilter</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>955825A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:34:01.146Z</lastUpdated>
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    <udiDi>06971162810131</udiDi>
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    <tradeName>06971162810131</tradeName>
    <deviceName>Hemodialysis Catheter</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>033001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:31:06.285Z</lastUpdated>
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    <udiDi>06971162810056</udiDi>
    <basicUdiDi>69368412HC03R2</basicUdiDi>
    <tradeName>06971162810056</tradeName>
    <deviceName>Hemodialysis Catheter</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:31:02.199Z</lastUpdated>
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    <udiDi>00842289103702</udiDi>
    <basicUdiDi>08422891FLUIDDETECTSH</basicUdiDi>
    <tradeName>NxStage Fluid Detection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX1373</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:14:45.025Z</lastUpdated>
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    <udiDi>30197990001221</udiDi>
    <basicUdiDi>0197990B00000021KH</basicUdiDi>
    <tradeName>Ritus™ Safety Fistula Cannula with Anti-reflux Valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mozarc Medical US LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043425</manufacturerSrn>
    <authorisedRepresentativeName>Mozarc Medical Ireland Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000048547</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1638VSMM</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:10:18.900Z</lastUpdated>
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    <udiDi>00884908165692</udiDi>
    <basicUdiDi>00884908105MQ</basicUdiDi>
    <tradeName>Tesio and Chronic Twinline Repair Kit</tradeName>
    <deviceName>Tesio and Chronic Twinline Repair Kits</deviceName>
    <manufacturerName>Medical Components, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008230</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NITSL-EXT-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:39:50.760Z</lastUpdated>
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    <udiDi>H67140005070</udiDi>
    <basicUdiDi>++H671CE018IN6</basicUdiDi>
    <tradeName>Dialy-Nate</tradeName>
    <deviceName>Dialy-Nate</deviceName>
    <manufacturerName>Utah Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020583</manufacturerSrn>
    <authorisedRepresentativeName>Utah Medical Products Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007796</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F900101</emdnCode>
    <emdnDescription>PERITONEAL DIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4000507</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:39:03.880Z</lastUpdated>
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  <row>
    <udiDi>D-SLC-1020DK2EQ</udiDi>
    <basicUdiDi>B-SLC-1020DK2EQ</basicUdiDi>
    <tradeName>Adhe-FLOW® MONO  Désilet kit cathéter d’hémodialyse fémorale  mono lumière FR10 L.: 20cm</tradeName>
    <deviceName>Adhe-FLOW® MONO  Désilet kit cathéter d’hémodialyse fémorale mono lumière FR10 L.: 20cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-1020DK2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:20.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SLC-1018DK1G3</udiDi>
    <basicUdiDi>B-SLC-1018DK1G3</basicUdiDi>
    <tradeName>Adhe-FLOW® MONO Désilet kit cathéter d’hémodialyse fémorale  mono lumière FR10 L.: 18cm</tradeName>
    <deviceName>Adhe-FLOW® MONO Désilet kit cathéter d’hémodialyse fémorale  mono lumière FR10 L.:18cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-1018DK1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:18.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SLC-1018DK-CHG6</udiDi>
    <basicUdiDi>B-SLC-1018DK-CHG6</basicUdiDi>
    <tradeName>Adhe-FLOW® MONO  Désilet kit cathéter d’hémodialyse fémorale  mono lumière FR10 L.: 18cm</tradeName>
    <deviceName>Adhe-FLOW® MONO Désilet kit cathéter d’hémodialyse fémorale  mono lumière FR10 L.: 18cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-1018DK-CH</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:17.846Z</lastUpdated>
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  <row>
    <udiDi>M535PAK0010</udiDi>
    <basicUdiDi>B-M535PAK0010</basicUdiDi>
    <tradeName>PUREFLOW SL PAK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAK-001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:22.179Z</lastUpdated>
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  <row>
    <udiDi>M535NX200040</udiDi>
    <basicUdiDi>B-M535NX200040</basicUdiDi>
    <tradeName>PUREFLOW SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX2000-4</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:18.170Z</lastUpdated>
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  <row>
    <udiDi>M535NX20002EU0</udiDi>
    <basicUdiDi>B-M535NX20002EU0</basicUdiDi>
    <tradeName>PUREFLOW SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NX2000-2-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:17.372Z</lastUpdated>
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  <row>
    <udiDi>M535NX20001A0</udiDi>
    <basicUdiDi>B-M535NX20001A0</basicUdiDi>
    <tradeName>PUREFLOW SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NX2000-1-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:16.573Z</lastUpdated>
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  <row>
    <udiDi>M535NX200011EU0</udiDi>
    <basicUdiDi>B-M535NX200011EU0</basicUdiDi>
    <tradeName>PUREFLOW SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX2000-11-EU</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:15.763Z</lastUpdated>
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  <row>
    <udiDi>M535NX13730</udiDi>
    <basicUdiDi>B-M535NX13730</basicUdiDi>
    <tradeName>NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX1373</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:11.872Z</lastUpdated>
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  <row>
    <udiDi>M535NX2000100</udiDi>
    <basicUdiDi>B-M535NX2000100</basicUdiDi>
    <tradeName>PUREFLOW SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX2000-10</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:10.164Z</lastUpdated>
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  <row>
    <udiDi>M535NX200010</udiDi>
    <basicUdiDi>B-M535NX200010</basicUdiDi>
    <tradeName>PUREFLOW SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NX2000-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:09.511Z</lastUpdated>
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