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    <basicUdiDi>955524040DP1SEF</basicUdiDi>
    <tradeName>Dialysis Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>061PC05017A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:39:51.882Z</lastUpdated>
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    <udiDi>09555240405227</udiDi>
    <basicUdiDi>955524040DP1SEF</basicUdiDi>
    <tradeName>Dialysis Kit - ON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>061PC05016A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:39:51.815Z</lastUpdated>
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    <udiDi>04044071249728</udiDi>
    <basicUdiDi>B-04044071249728</basicUdiDi>
    <tradeName>Dialysis connection and disconnection sets</tradeName>
    <deviceName>Dialysis connection and disconnection sets</deviceName>
    <manufacturerName>Bionic Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012048</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KPA06048-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:33:26.420Z</lastUpdated>
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    <udiDi>04044071249711</udiDi>
    <basicUdiDi>B-04044071249711</basicUdiDi>
    <tradeName>Dialysis connection and disconnection sets</tradeName>
    <deviceName>Dialysis connection and disconnection sets</deviceName>
    <manufacturerName>Bionic Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012048</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KPA06047-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:33:24.826Z</lastUpdated>
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  <row>
    <udiDi>04044071221946</udiDi>
    <basicUdiDi>B-04044071221946</basicUdiDi>
    <tradeName>Dialysis connection and disconnection sets</tradeName>
    <deviceName>Dialysis connection and disconnection sets</deviceName>
    <manufacturerName>Bionic Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012048</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KPA06006-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:33:22.430Z</lastUpdated>
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  <row>
    <udiDi>06979847281184</udiDi>
    <basicUdiDi>6979847286979847281184C8</basicUdiDi>
    <tradeName>Dialysis  On &amp; Off Kits</tradeName>
    <deviceName>Dialysis  On &amp; Off Kits</deviceName>
    <manufacturerName>Hubei Lanbin Medical Group Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049717</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMDNS Code</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:50:36.556Z</lastUpdated>
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    <udiDi>03800232427852</udiDi>
    <basicUdiDi>380023TD06DIAIIBWH</basicUdiDi>
    <tradeName>DIALYSIS PACK</tradeName>
    <deviceName>Kit inizio/termine latex free</deviceName>
    <manufacturerName>STS Medical Group AD</manufacturerName>
    <manufacturerSrn>BG-PR-000041814</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29831-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:22:43.914Z</lastUpdated>
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    <udiDi>08056214180009</udiDi>
    <basicUdiDi>805621418DIALA2</basicUdiDi>
    <tradeName>KIT DIALISI EXTRA-CORPOREA CON TLTP-05</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIVAL SRL</manufacturerName>
    <manufacturerSrn>IT-PR-000040726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KTMDVU25000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:09:08.986Z</lastUpdated>
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    <udiDi>04260430940109</udiDi>
    <basicUdiDi>426043094OPALSETGS</basicUdiDi>
    <tradeName>OPAL I Behandlungsset Premium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>80004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:09.288Z</lastUpdated>
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    <udiDi>04260430940598</udiDi>
    <basicUdiDi>426043094ALBUNIQUESETPE</basicUdiDi>
    <tradeName>ALBUNIQUE® ECAD Set MF 2 Citrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80007-MF2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:09.040Z</lastUpdated>
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    <udiDi>04260430940604</udiDi>
    <basicUdiDi>426043094ALBUNIQUESETPE</basicUdiDi>
    <tradeName>ALBUNIQUE® ECAD Set MF 3 Citrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80007-MF3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:09.023Z</lastUpdated>
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    <udiDi>04260430940611</udiDi>
    <basicUdiDi>426043094ALBUNIQUESETPE</basicUdiDi>
    <tradeName>ALBUNIQUE® ECAD Set MF 4 Citrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80007-MF4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:09.005Z</lastUpdated>
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    <udiDi>04260430940628</udiDi>
    <basicUdiDi>426043094OPALSETGS</basicUdiDi>
    <tradeName>OPAL® II Behandlungsset Classic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80003-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:08.993Z</lastUpdated>
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    <udiDi>04260430940666</udiDi>
    <basicUdiDi>426043094ALBUNIQUESETPE</basicUdiDi>
    <tradeName>ALBUNIQUE® ECAD Set MFP 1 Citrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80007-MFP1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:08.934Z</lastUpdated>
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    <udiDi>04260430940833</udiDi>
    <basicUdiDi>426043094ALBUNIQUESETPE</basicUdiDi>
    <tradeName>ALBUNIQUE® ECAD Set MFP 2 Citrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80007-MFP2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:08.845Z</lastUpdated>
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    <udiDi>04260430940840</udiDi>
    <basicUdiDi>426043094OPALSETGS</basicUdiDi>
    <tradeName>OPAL® II Behandlungsset MC5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000009770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80003-II-MC5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:32:08.822Z</lastUpdated>
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    <udiDi>03800238372385</udiDi>
    <basicUdiDi>380023TD06DIAIIBWH</basicUdiDi>
    <tradeName>Kit inizio/termine latex free</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STS Medical Group AD</manufacturerName>
    <manufacturerSrn>BG-PR-000041814</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10005-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:35:51.792Z</lastUpdated>
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    <udiDi>05600743460113</udiDi>
    <basicUdiDi>5600743460KITDPYN</basicUdiDi>
    <tradeName>Kit de Diálise Peritoneal - Programa Fresenius</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BY CARE, LDA.</manufacturerName>
    <manufacturerSrn>PT-PR-000047291</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC 22002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T08:45:41.945Z</lastUpdated>
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