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<eudamedExport entity="devices">
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    <udiDi>04806538161369</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>630-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:31.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161376</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>630-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:29.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160324</udiDi>
    <basicUdiDi>B-04806538160324</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>D17AV2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:51.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160317</udiDi>
    <basicUdiDi>B-04806538160317</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>D17AV2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:48.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160300</udiDi>
    <basicUdiDi>B-04806538160300</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>D17V2530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:48.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160294</udiDi>
    <basicUdiDi>B-04806538160294</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>D17V2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:43.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160287</udiDi>
    <basicUdiDi>B-04806538160287</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>D17V2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:43.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160270</udiDi>
    <basicUdiDi>B-04806538160270</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>D17V2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:42.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160263</udiDi>
    <basicUdiDi>B-04806538160263</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>D17A2530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:41.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160256</udiDi>
    <basicUdiDi>B-04806538160256</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>D17A2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:15:36.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161291</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</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>MDR 2017/745</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040-AGAM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:06:57.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161314</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:55:08.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160249</udiDi>
    <basicUdiDi>B-04806538160249</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>D17A2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:02.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160232</udiDi>
    <basicUdiDi>B-04806538160232</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>D17A2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:00.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160225</udiDi>
    <basicUdiDi>B-04806538160225</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>D16AV2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:58.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160218</udiDi>
    <basicUdiDi>B-04806538160218</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>D16AV2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:58.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160201</udiDi>
    <basicUdiDi>B-04806538160201</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>D16AV2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:56.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160195</udiDi>
    <basicUdiDi>B-04806538160195</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>D16V2530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:53.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160188</udiDi>
    <basicUdiDi>B-04806538160188</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>D16V2515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:52.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160164</udiDi>
    <basicUdiDi>B-04806538160164</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>D16V2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:35:52.290Z</lastUpdated>
  </row>
</eudamedExport>