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<eudamedExport entity="devices">
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    <basicUdiDi>B-04806538160119</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15AV2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:27.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160102</udiDi>
    <basicUdiDi>B-04806538160102</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15AV2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:25.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160096</udiDi>
    <basicUdiDi>B-04806538160096</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15AV2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:23.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160089</udiDi>
    <basicUdiDi>B-04806538160089</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15V2530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:22.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160072</udiDi>
    <basicUdiDi>B-04806538160072</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15V2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:22.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160065</udiDi>
    <basicUdiDi>B-04806538160065</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15V2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:18.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160058</udiDi>
    <basicUdiDi>B-04806538160058</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15V2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:17.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160041</udiDi>
    <basicUdiDi>B-04806538160041</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15A2530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:13.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160034</udiDi>
    <basicUdiDi>B-04806538160034</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15A2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:13.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160027</udiDi>
    <basicUdiDi>B-04806538160027</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15A2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:11.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160010</udiDi>
    <basicUdiDi>B-04806538160010</basicUdiDi>
    <tradeName>BUTTERFLY AVF</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15A2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:09.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033254738346</udiDi>
    <basicUdiDi>803325473120200101YZ</basicUdiDi>
    <tradeName>Dialine</tradeName>
    <deviceName>LK711079R</deviceName>
    <manufacturerName>F.M. SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000028573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK711079R</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:46:57.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>26939348145679</udiDi>
    <basicUdiDi>6939348121040062a010101B8</basicUdiDi>
    <tradeName>Hemodialysis bloodline</tradeName>
    <deviceName>Hemodialysis bloodline</deviceName>
    <manufacturerName>Chengdu Xinjin Shifeng Medical Apparatus &amp; Instrument  Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016493</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK.BPC-014</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:44:04.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945060593946</udiDi>
    <basicUdiDi>69450605SX005PQ</basicUdiDi>
    <tradeName>Sansin</tradeName>
    <deviceName>Hemodialysis Blood Tubing Sets</deviceName>
    <manufacturerName>Jiangxi Sanxin Medtec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018456</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HDL-B36</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:41:17.339Z</lastUpdated>
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  <row>
    <udiDi>04260157726116</udiDi>
    <basicUdiDi>426015772AVBLOODLINERQT</basicUdiDi>
    <tradeName>04260157726116</tradeName>
    <deviceName>Arterial and Venous Bloodline</deviceName>
    <manufacturerName>Allmed Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV/204/1+B+IV</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:16:40.183Z</lastUpdated>
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  <row>
    <udiDi>BLSR</udiDi>
    <basicUdiDi>++G401BLSR2</basicUdiDi>
    <tradeName>Blood Lines Set</tradeName>
    <deviceName>Blood Lines Set</deviceName>
    <manufacturerName>Disposafe Health &amp; Lifecare Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000020265</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020180</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:41:48.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535CAR125B0</udiDi>
    <basicUdiDi>B-M535CAR125B0</basicUdiDi>
    <tradeName>NXSTAGE CARTRIDGE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020104</emdnCode>
    <emdnDescription>REINFUSION DIALYSIS LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-125-B</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:26.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535CAR124C0</udiDi>
    <basicUdiDi>B-M535CAR124C0</basicUdiDi>
    <tradeName>NXSTAGE CARTRIDGE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020104</emdnCode>
    <emdnDescription>REINFUSION DIALYSIS LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-124-C</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:24.540Z</lastUpdated>
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    <udiDi>D-868475920017P8</udiDi>
    <basicUdiDi>B-868475920017P8</basicUdiDi>
    <tradeName>NephroLine</tradeName>
    <deviceName>Blood tubing sets for hemodialysis (Blood lines)</deviceName>
    <manufacturerName>NEPHROCAN MEDİKAL SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000046244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4212725</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:27:35.200Z</lastUpdated>
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    <udiDi>D-868475920016P6</udiDi>
    <basicUdiDi>B-868475920016P6</basicUdiDi>
    <tradeName>NephroLine</tradeName>
    <deviceName>Blood tubing sets for hemodialysis (Blood lines)</deviceName>
    <manufacturerName>NEPHROCAN MEDİKAL SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000046244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4212715</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:27:33.381Z</lastUpdated>
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</eudamedExport>