<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-862-1646B2</udiDi>
    <basicUdiDi>B-862-1646B2</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R20B15SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:23.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1645AY</udiDi>
    <basicUdiDi>B-862-1645AY</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V16R20-30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:19.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1644AW</udiDi>
    <basicUdiDi>B-862-1644AW</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R20B30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:18.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1643AU</udiDi>
    <basicUdiDi>B-862-1643AU</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R25B15SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:17.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1642AS</udiDi>
    <basicUdiDi>B-862-1642AS</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V16R25-15SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:17.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1641AQ</udiDi>
    <basicUdiDi>B-862-1641AQ</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R25B30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:13.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1640AN</udiDi>
    <basicUdiDi>B-862-1640AN</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V16R25-30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:12.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1639B5</udiDi>
    <basicUdiDi>B-862-1639B5</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V16R25-30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:11.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1638B3</udiDi>
    <basicUdiDi>B-862-1638B3</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V16R25-15S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:10.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1637AZ</udiDi>
    <basicUdiDi>B-862-1637AZ</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R25B30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:06.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1636AX</udiDi>
    <basicUdiDi>B-862-1636AX</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R25B15S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:05.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1635AV</udiDi>
    <basicUdiDi>B-862-1635AV</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V16R20-30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:05.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1634AT</udiDi>
    <basicUdiDi>B-862-1634AT</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R20B30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:04.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1633AR</udiDi>
    <basicUdiDi>B-862-1633AR</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V16R20-15S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:00.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1632AP</udiDi>
    <basicUdiDi>B-862-1632AP</basicUdiDi>
    <tradeName>HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set</tradeName>
    <deviceName>SYSLOC AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A16R20B15S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:21:59.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1535AQ</udiDi>
    <basicUdiDi>B-862-1535AQ</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V15R20-30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:21:58.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1534AN</udiDi>
    <basicUdiDi>B-862-1534AN</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A15R20B30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:21:58.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1533AL</udiDi>
    <basicUdiDi>B-862-1533AL</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A15R25B15SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:21:53.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1532AJ</udiDi>
    <basicUdiDi>B-862-1532AJ</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V15R25-15SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:21:53.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1531AG</udiDi>
    <basicUdiDi>B-862-1531AG</basicUdiDi>
    <tradeName>HEMO PHENIX A.V. Fistula Needle Set</tradeName>
    <deviceName>HEMO PHENIX AVF</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A15R25B30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:21:52.221Z</lastUpdated>
  </row>
</eudamedExport>