<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-862-1530AE</udiDi>
    <basicUdiDi>B-862-1530AE</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>V15R25-30SP+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:21:51.438Z</lastUpdated>
  </row>
  <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>D-814-06458W</udiDi>
    <basicUdiDi>B-814-06458W</basicUdiDi>
    <tradeName>JMS Transfer Bag</tradeName>
    <deviceName>Transfer Bag</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B010299</emdnCode>
    <emdnDescription>BLOOD TRANSFER BAGS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>814-0645</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:09.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-811-409788</udiDi>
    <basicUdiDi>B-811-409788</basicUdiDi>
    <tradeName>JMS Blood Bag</tradeName>
    <deviceName>Blood Bag</deviceName>
    <manufacturerName>JMS Singapore Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024704</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B0101020299</emdnCode>
    <emdnDescription>DONOR BLOOD COLLECTION BAGS W/O FILTERS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811-4097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:56:58.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987494339334</udiDi>
    <basicUdiDi>4987494001EU</basicUdiDi>
    <tradeName>04987494339334</tradeName>
    <deviceName>JMS Tongue Pressure Measurement Device</deviceName>
    <manufacturerName>JMS CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000021805</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIMENSIONAL CLINICAL PARAMETERS MEASURING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JM-TPM02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:06.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>54806538160015</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>54806538160015</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>D15A2015</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:47:36.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987494185887</udiDi>
    <basicUdiDi>B-04987494185887</basicUdiDi>
    <tradeName>JMS DISPOSABLE SYRINGE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>JMS CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000021805</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>551721052</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:38.587Z</lastUpdated>
  </row>
</eudamedExport>