<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>19555240404098</udiDi>
    <basicUdiDi>955524040TOUNSMN</basicUdiDi>
    <tradeName>ITL EssentialsTM Tourniquet B&amp;B Thick Strap 45cm NS</tradeName>
    <deviceName>Tourniquet</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>V9003</emdnCode>
    <emdnDescription>TOURNIQUETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A600001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:39.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240401400</udiDi>
    <basicUdiDi>955524040TCSSJZ</basicUdiDi>
    <tradeName>Transfer Cap Set</tradeName>
    <deviceName>Transfer Cap Set</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A100730</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:37.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240401196</udiDi>
    <basicUdiDi>955524040SPTNSMD</basicUdiDi>
    <tradeName>ITL EssentialsTM Sharps Passing Tray Small NS</tradeName>
    <deviceName>Sharps Passing Tray</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>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A500102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:35.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240401158</udiDi>
    <basicUdiDi>955524040SSSR2</basicUdiDi>
    <tradeName>SampLok® System with Hinged Lid</tradeName>
    <deviceName>SampLok</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010180</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100645</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:34.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240401134</udiDi>
    <basicUdiDi>955524040ACSLQ</basicUdiDi>
    <tradeName>SampLok® Adapter Cap with Male Luer</tradeName>
    <deviceName>Adapter Cap</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010180</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100710</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:33.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240400960</udiDi>
    <basicUdiDi>955524040CCNSET</basicUdiDi>
    <tradeName>CrocClampTM Non-Reopening Clamp</tradeName>
    <deviceName>CrocClamp</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:30.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240400854</udiDi>
    <basicUdiDi>955524040QVRSM8</basicUdiDi>
    <tradeName>ITL EssentialsTM Quiver Laparoscopic Extendable with PVC Loop</tradeName>
    <deviceName>Quiver</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>Z12010999</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100604</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:29.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240400557</udiDi>
    <basicUdiDi>955524040QVRNSMP</basicUdiDi>
    <tradeName>ITL EssentialsTM Quiver with PVC Loop NS</tradeName>
    <deviceName>Quiver</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>Z12010999</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100396</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:28.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240400137</udiDi>
    <basicUdiDi>955524040NGNSHU</basicUdiDi>
    <tradeName>DonorCare® Needle Guard Small Channel</tradeName>
    <deviceName>Needle Guard</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>A018001</emdnCode>
    <emdnDescription>NEEDLE CAPS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:26.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240400069</udiDi>
    <basicUdiDi>955524040SAMPLOKNSSC</basicUdiDi>
    <tradeName>SampLok® with Hinged Lid</tradeName>
    <deviceName>SampLok</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010180</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100422</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:24.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555240400045</udiDi>
    <basicUdiDi>955524040SSNSLT</basicUdiDi>
    <tradeName>SampLok® System with Hinged Lid</tradeName>
    <deviceName>SampLok</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010180</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A100648</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:20:22.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404985</udiDi>
    <basicUdiDi>955524040SCUSJY</basicUdiDi>
    <tradeName>SCU Wide Cap Sampler</tradeName>
    <deviceName>Safety SubCulture Unit</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A100723</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:39.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240404183</udiDi>
    <basicUdiDi>955524040IV1SGG</basicUdiDi>
    <tradeName>Intravenous Start Kit</tradeName>
    <deviceName>Intravenous Start Kit</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>061PC09080A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:37.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240403827</udiDi>
    <basicUdiDi>955524040DP1SEF</basicUdiDi>
    <tradeName>Dialysis Kit</tradeName>
    <deviceName>Dialysis Pack</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>F0399</emdnCode>
    <emdnDescription>DIALYSIS KITS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>061PC05014A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:37.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240403810</udiDi>
    <basicUdiDi>955524040PP1SH3</basicUdiDi>
    <tradeName>SINGLE SWAB STICK ORANGE 8"</tradeName>
    <deviceName>Procedure Pack</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>21BB/1140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:35.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401601</udiDi>
    <basicUdiDi>955524040SPTSLW</basicUdiDi>
    <tradeName>ITL EssentialsTM Sharps Passing Tray Large</tradeName>
    <deviceName>Sharps Passing Tray</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>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A500117</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:33.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401526</udiDi>
    <basicUdiDi>955524040ACNSED</basicUdiDi>
    <tradeName>SampLok® Adapter Cap 3</tradeName>
    <deviceName>Adapter Cap</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010180</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A100760</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:31.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240400536</udiDi>
    <basicUdiDi>955524040SSKSLJ</basicUdiDi>
    <tradeName>SampLok® Sampling Kit 16mL</tradeName>
    <deviceName>SampLok Sampling Kit</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>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A100740</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:30.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401915</udiDi>
    <basicUdiDi>B-09555240401915</basicUdiDi>
    <tradeName>SINGLE TRANSDUCER 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>LS-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T01:57:13.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240402059</udiDi>
    <basicUdiDi>B-09555240402059</basicUdiDi>
    <tradeName>TRANSDUCER SINGLE ART. ABSS 50 CM ARM MOUNT (30CM)</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>LS-221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T01:57:13.180Z</lastUpdated>
  </row>
</eudamedExport>