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    <tradeName>ULTRALINE HDF</tradeName>
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    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>ArtiSet HD DNL HC</tradeName>
    <deviceName>ArtiSet HD DNL HC</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
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    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
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    <tradeName>SP-235 ACCESSORY RE-INFUSION LINE</tradeName>
    <deviceName>S-1016 Accessory Connector</deviceName>
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    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
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    <lastUpdated>2026-07-29T20:09:06.130Z</lastUpdated>
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    <tradeName>S-660-C ACCESSORY "Y" CONNECTOR</tradeName>
    <deviceName>S-660-C Accessory “Y” Connector</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020180</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101354</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:09:01.130Z</lastUpdated>
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    <udiDi>07332414004095</udiDi>
    <basicUdiDi>7332414VA0000783L</basicUdiDi>
    <tradeName>C-705 ACCESSORY EXPANSION CHAMBER</tradeName>
    <deviceName>SINGLE NEEDLE EXPANSION CHAMBER C-705</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>
    <emdnCode>F020180</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101739</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:09:00.434Z</lastUpdated>
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    <udiDi>06948082708718</udiDi>
    <basicUdiDi>6948082701183AA</basicUdiDi>
    <tradeName>DORA Tubing Sets for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-112G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:27.751Z</lastUpdated>
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    <tradeName>DORA Tubing Sets for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-114G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:27.712Z</lastUpdated>
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    <tradeName>DORA Tubing Sets for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-116G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:27.674Z</lastUpdated>
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    <udiDi>04806538161284</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>030-AGAM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:51:32.433Z</lastUpdated>
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    <udiDi>04806538160362</udiDi>
    <basicUdiDi>B-04806538160362</basicUdiDi>
    <tradeName>04806538160362</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>F00012257</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:49:02.632Z</lastUpdated>
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    <udiDi>04806538160355</udiDi>
    <basicUdiDi>B-04806538160355</basicUdiDi>
    <tradeName>04806538160355</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>F00012251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:49:01.828Z</lastUpdated>
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    <udiDi>04806538160348</udiDi>
    <basicUdiDi>B-04806538160348</basicUdiDi>
    <tradeName>04806538160348</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>F00012256</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:49:01.030Z</lastUpdated>
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    <udiDi>04806538160331</udiDi>
    <basicUdiDi>B-04806538160331</basicUdiDi>
    <tradeName>04806538160331</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>F00012250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:49:00.259Z</lastUpdated>
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    <udiDi>04806538160423</udiDi>
    <basicUdiDi>B-04806538160423</basicUdiDi>
    <tradeName>04806538160423</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>F00012260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:37:03.169Z</lastUpdated>
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    <tradeName>04806538160447</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00012261</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:37:01.564Z</lastUpdated>
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    <udiDi>04806538160430</udiDi>
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    <tradeName>04806538160430</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00012255</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:37:00.763Z</lastUpdated>
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    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00012254</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:36:59.175Z</lastUpdated>
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    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00012259</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:36:43.900Z</lastUpdated>
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    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00012253</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:36:43.102Z</lastUpdated>
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    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F00012258</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:36:42.289Z</lastUpdated>
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