<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-1610KGU</udiDi>
    <basicUdiDi>B-1610KGU</basicUdiDi>
    <tradeName>Paediatric TegadermTM IV Starter Kit 1610K</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1610K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1633KBRS</udiDi>
    <basicUdiDi>B-1633KBRS</basicUdiDi>
    <tradeName>TegadermTM IV Starter Kit 1633KB BASIC (No Tourniquet)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1633KB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1633KHF</udiDi>
    <basicUdiDi>B-1633KHF</basicUdiDi>
    <tradeName>TegadermTM IV Starter Kit 1633K</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1633K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1683KBSV</udiDi>
    <basicUdiDi>B-1683KBSV</basicUdiDi>
    <tradeName>TegadermTM IV Advanced Starter Kit 1683KB BASIC (No Tourniquet)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1683KB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1683KJ8</udiDi>
    <basicUdiDi>B-1683KJ8</basicUdiDi>
    <tradeName>TegadermTM IV Advanced Starter Kit 1683K</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1683K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240402387</udiDi>
    <basicUdiDi>B-09555240402387</basicUdiDi>
    <tradeName>NEURO PRESSURE MEASUREMENT LINE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T13:53:26.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401847</udiDi>
    <basicUdiDi>B-09555240401847</basicUdiDi>
    <tradeName>ARTERIAL KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240403322</udiDi>
    <basicUdiDi>B-09555240403322</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240403360</udiDi>
    <basicUdiDi>B-09555240403360</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240403377</udiDi>
    <basicUdiDi>B-09555240403377</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240403452</udiDi>
    <basicUdiDi>B-09555240403452</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404060</udiDi>
    <basicUdiDi>B-09555240404060</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404138</udiDi>
    <basicUdiDi>B-09555240404138</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404237</udiDi>
    <basicUdiDi>B-09555240404237</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404312</udiDi>
    <basicUdiDi>B-09555240404312</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404336</udiDi>
    <basicUdiDi>955524040IV1SGG</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404374</udiDi>
    <basicUdiDi>955524040IV1SGG</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404954</udiDi>
    <basicUdiDi>B-09555240404954</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404978</udiDi>
    <basicUdiDi>B-09555240404978</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240405050</udiDi>
    <basicUdiDi>B-09555240405050</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T00:08:38.137Z</lastUpdated>
  </row>
</eudamedExport>