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    <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>830-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:15.551Z</lastUpdated>
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    <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>
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    <reference>840-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:04.103Z</lastUpdated>
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    <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>850-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>04806538160812</udiDi>
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    <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>850-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:39.170Z</lastUpdated>
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  <row>
    <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>
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  <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>
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    <udiDi>26939348193328</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>many</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:07:30.881Z</lastUpdated>
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    <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>many</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:00:46.834Z</lastUpdated>
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    <udiDi>26939348193212</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>many</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:53:42.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>26939348193038</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>many</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:46:58.509Z</lastUpdated>
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  <row>
    <udiDi>26939348192994</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-020</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:38:01.219Z</lastUpdated>
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  <row>
    <udiDi>26939348192987</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-070</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:31:15.875Z</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>
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  <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>
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