<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>58888483002479</udiDi>
    <basicUdiDi>B-58888483002479</basicUdiDi>
    <tradeName>JMS SysLoc Safety 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>862-1700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:51:37.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>58888483002462</udiDi>
    <basicUdiDi>B-58888483002462</basicUdiDi>
    <tradeName>JMS SysLoc Safety 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>862-1607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:51:32.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>58888483002455</udiDi>
    <basicUdiDi>B-58888483002455</basicUdiDi>
    <tradeName>JMS SysLoc Safety 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>862-1606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:51:31.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>58888483002448</udiDi>
    <basicUdiDi>B-58888483002448</basicUdiDi>
    <tradeName>JMS SysLoc Safety 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>862-1507</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:51:31.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>58888483002431</udiDi>
    <basicUdiDi>B-58888483002431</basicUdiDi>
    <tradeName>JMS SysLoc Safety 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>862-1506</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:51:30.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>58888483000192</udiDi>
    <basicUdiDi>B-58888483000192</basicUdiDi>
    <tradeName>JMS A.V. Fistula Needle Set</tradeName>
    <deviceName>AVF FIXED WING</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>820-1625</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:50:38.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>58888483000178</udiDi>
    <basicUdiDi>B-58888483000178</basicUdiDi>
    <tradeName>JMS A.V. Fistula Needle Set</tradeName>
    <deviceName>AVF FIXED WING</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>820-1509</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:50:37.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488097943</udiDi>
    <basicUdiDi>4987488AVF_HD_KR</basicUdiDi>
    <tradeName>A. V. Fistula Sets for Hemodialysis</tradeName>
    <deviceName>A. V. Fistula Sets for Hemodialysis</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF1625CPLFG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:39.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488097127</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</tradeName>
    <deviceName>Arterial Venous Fistula Set</deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-5314EMG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:39.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543527252966</udiDi>
    <basicUdiDi>4543527SupercathPRO_CC</basicUdiDi>
    <tradeName>Supercath PRO</tradeName>
    <deviceName>Supercath PRO</deviceName>
    <manufacturerName>Togo Medikit Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000013805</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP402-14(25)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:01.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543527240710</udiDi>
    <basicUdiDi>4543527SupercathNEO_9V</basicUdiDi>
    <tradeName>Supercath NEO</tradeName>
    <deviceName>Supercath NEO</deviceName>
    <manufacturerName>Togo Medikit Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000013805</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP802-14(25)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:25:00.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543527000765</udiDi>
    <basicUdiDi>4543527Clampcath_EA</basicUdiDi>
    <tradeName>Supercath Clampcath</tradeName>
    <deviceName>Supercath Clampcath</deviceName>
    <manufacturerName>Togo Medikit Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000013805</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP502-16(33)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:24:59.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157724327</udiDi>
    <basicUdiDi>426015772FNEEDLEEO2K</basicUdiDi>
    <tradeName>04260157724327</tradeName>
    <deviceName>Arterial Venous Dialysis Fistula Needle</deviceName>
    <manufacturerName>Allmed Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010499</emdnCode>
    <emdnDescription>DIALYSIS NEEDLES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>FN14GAR/30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:16:39.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>AVFQZ</udiDi>
    <basicUdiDi>++G401AVFQZ</basicUdiDi>
    <tradeName>A.V. Fistula Needle Set</tradeName>
    <deviceName>A.V. Fistula Needle Set</deviceName>
    <manufacturerName>Disposafe Health &amp; Lifecare Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000020265</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:41:40.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1726AZ</udiDi>
    <basicUdiDi>B-862-1726AZ</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>V17R20-30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:30.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1725AX</udiDi>
    <basicUdiDi>B-862-1725AX</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>A17R20B30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:29.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1724AV</udiDi>
    <basicUdiDi>B-862-1724AV</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>V17R20-30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:25.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1723AT</udiDi>
    <basicUdiDi>B-862-1723AT</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>A17R20B30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:25.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1647B4</udiDi>
    <basicUdiDi>B-862-1647B4</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>V16R20-15SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:22:24.235Z</lastUpdated>
  </row>
  <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>
</eudamedExport>