<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09555240401847</udiDi>
    <basicUdiDi>B-09555240401847</basicUdiDi>
    <tradeName>ARTERIAL KIT</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-084</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:59.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401830</udiDi>
    <basicUdiDi>B-09555240401830</basicUdiDi>
    <tradeName>IBPM Triple Pole DC Art /CVP/PA 390cm</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-083</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:58.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401823</udiDi>
    <basicUdiDi>B-09555240401823</basicUdiDi>
    <tradeName>SINGLE TRANSDUCER KIT ICU</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-066</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:57.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401809</udiDi>
    <basicUdiDi>B-09555240401809</basicUdiDi>
    <tradeName>TRIPLE TRANSDUCER KIT</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-056</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:56.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401793</udiDi>
    <basicUdiDi>B-09555240401793</basicUdiDi>
    <tradeName>DOUBLE TRANSDUCER KIT</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-055</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:52.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401786</udiDi>
    <basicUdiDi>B-09555240401786</basicUdiDi>
    <tradeName>ARTERIAL PRESSURE MONITORING KIT</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:51.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401779</udiDi>
    <basicUdiDi>B-09555240401779</basicUdiDi>
    <tradeName>SINGLE CVC PRESSURE MONITORING KIT</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:51.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401748</udiDi>
    <basicUdiDi>B-09555240401748</basicUdiDi>
    <tradeName>IBPM Single 150cm</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:50.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401670</udiDi>
    <basicUdiDi>B-09555240401670</basicUdiDi>
    <tradeName>MONITORING KIT</tradeName>
    <deviceName>IBPM Kits</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>MDD</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LS-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:05:44.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348099</udiDi>
    <basicUdiDi>B-09421902348099</basicUdiDi>
    <tradeName>extendSURE™ HbA1c Liquid Controls</tradeName>
    <deviceName>extendSURE™ HbA1c Liquid Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B12397</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:56.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348075</udiDi>
    <basicUdiDi>B-09421902348075</basicUdiDi>
    <tradeName>extendSURETM Haemoglobin A1c Lyophilised Controls</tradeName>
    <deviceName>extendSURETM Haemoglobin A1c Lyophilised Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB710SBAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:54.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348044</udiDi>
    <basicUdiDi>B-09421902348044</basicUdiDi>
    <tradeName>extendSURETM Haemoglobin F and A2 Calibrators</tradeName>
    <deviceName>extendSURETM Haemoglobin F and A2 Calibrators</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB110SCALAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:52.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348037</udiDi>
    <basicUdiDi>B-09421902348037</basicUdiDi>
    <tradeName>extendSURE™ Haemoglobin F and A2 Controls</tradeName>
    <deviceName>extendSURE™ Haemoglobin F and A2 Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB110SSBAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:50.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348006</udiDi>
    <basicUdiDi>B-09421902348006</basicUdiDi>
    <tradeName>extendSURE™ HbA1c Liquid Controls</tradeName>
    <deviceName>extendSURE™ HbA1c Liquid Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B12396</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:50.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>09369998142903</udiDi>
    <basicUdiDi>B-09369998142903</basicUdiDi>
    <tradeName>Navbit Sprint</tradeName>
    <deviceName>Navbit Sprint Device, Lateral Registration</deviceName>
    <manufacturerName>Navbit Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016920</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130401</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBS-00-002</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:04.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>09369998068180</udiDi>
    <basicUdiDi>B-09369998068180</basicUdiDi>
    <tradeName>Navbit Sprint</tradeName>
    <deviceName>Navbit Sprint Device, Supine Registration</deviceName>
    <manufacturerName>Navbit Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016920</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130401</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBS-00-001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:02.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351405001019</udiDi>
    <basicUdiDi>B-09351405001019</basicUdiDi>
    <tradeName>BP+</tradeName>
    <deviceName>BP+</deviceName>
    <manufacturerName>Uscom Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000023807</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U10200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:49.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351405000012</udiDi>
    <basicUdiDi>B-09351405000012</basicUdiDi>
    <tradeName>USCOM</tradeName>
    <deviceName>USCOM</deviceName>
    <manufacturerName>Uscom Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000023807</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050501</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U10001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:48.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904448607390</udiDi>
    <basicUdiDi>8908004933SLSPP1MZ</basicUdiDi>
    <tradeName>Mediten</tradeName>
    <deviceName></deviceName>
    <manufacturerName>St.Marys Rubbers Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008817</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>1LSPP- 1260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:41.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904448604894</udiDi>
    <basicUdiDi>8908004933SLSPP1MZ</basicUdiDi>
    <tradeName>Mediten</tradeName>
    <deviceName></deviceName>
    <manufacturerName>St.Marys Rubbers Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008817</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>1LSPP-1265</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:41.185Z</lastUpdated>
  </row>
</eudamedExport>