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<eudamedExport entity="devices">
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    <udiDi>04806538161444</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>550-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:19.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161451</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>330-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:19.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161482</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>330-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:18.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161468</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>340-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:13.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161499</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>340-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:12.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161475</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>350-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:12.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538161505</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>350-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:11.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303137</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-D-A(a1-b1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-D-A(a1-b1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303144</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-D-A(a1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-D-A(a1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303229</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-S-A(b1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-S-A(b1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303236</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-S-A(a1-b1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-S-A(a1-b1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303243</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-S-A(a1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-S-A(a1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303328</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-S-B(a1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-S-B(a1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303335</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-S-B(b1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-S-B(b1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303342</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-S-B(a1-b1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-S-B(a1-b1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303410</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-D-B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-D-B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303427</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-D-B(b2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-D-B(b2)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303434</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-D-B(a1-b2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-D-B(a1-b2)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303441</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-D-B(b1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-D-B(b1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937909303458</udiDi>
    <basicUdiDi>69379093HBTS001YB</basicUdiDi>
    <tradeName>OCI-BD-D-B(a1-b1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BD-D-B(a1-b1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:57.205Z</lastUpdated>
  </row>
</eudamedExport>