<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-862-1529AV</udiDi>
    <basicUdiDi>B-862-1529AV</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>V15R25-30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:20:20.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1528AT</udiDi>
    <basicUdiDi>B-862-1528AT</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>V15R25-15S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:20:20.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1527AR</udiDi>
    <basicUdiDi>B-862-1527AR</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>V15R20-30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:20:18.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1526AP</udiDi>
    <basicUdiDi>B-862-1526AP</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>A15R25B30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:20:17.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1525AM</udiDi>
    <basicUdiDi>B-862-1525AM</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>A15R25B15S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:20:16.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-862-1524AK</udiDi>
    <basicUdiDi>B-862-1524AK</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>A15R20B30S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:20:13.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109931</udiDi>
    <basicUdiDi>B-09555793109931</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2516LR02VSG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:20.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109924</udiDi>
    <basicUdiDi>B-09555793109924</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2016LR01ASG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:19.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109917</udiDi>
    <basicUdiDi>B-09555793109917</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2515LF02VSG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:15.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109719</udiDi>
    <basicUdiDi>B-09555793109719</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2517LR01ASG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:14.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109436</udiDi>
    <basicUdiDi>B-09555793109436</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Dull Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Dull Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF3215LR01ADG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:14.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109382</udiDi>
    <basicUdiDi>B-09555793109382</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2516LR01VSG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:13.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109375</udiDi>
    <basicUdiDi>B-09555793109375</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2515LR01VSG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:09.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109368</udiDi>
    <basicUdiDi>B-09555793109368</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2514LR01VSG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:08.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109351</udiDi>
    <basicUdiDi>B-09555793109351</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2516LR01ASG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:07.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109344</udiDi>
    <basicUdiDi>B-09555793109344</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2515LR01ASG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:06.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109337</udiDi>
    <basicUdiDi>B-09555793109337</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2514LR01ASG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:02.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109207</udiDi>
    <basicUdiDi>B-09555793109207</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2516LR01E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:02.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108668</udiDi>
    <basicUdiDi>B-09555793108668</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2517SR03TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:13.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108651</udiDi>
    <basicUdiDi>B-09555793108651</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2516SR03TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:12.386Z</lastUpdated>
  </row>
</eudamedExport>