<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-450202NG</udiDi>
    <basicUdiDi>B-450202NG</basicUdiDi>
    <tradeName>SYNCHRON Systems Protein Calibrator Levels 1 and 2</tradeName>
    <deviceName>SYNCHRON Systems Protein Calibrator Levels 1 and 2</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450202</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:21.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-449730R2</udiDi>
    <basicUdiDi>B-449730R2</basicUdiDi>
    <tradeName>Immunochemistry Systems CAL 3 Calibrator 3</tradeName>
    <deviceName>Immunochemistry Systems CAL 3 Calibrator 3</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>449730</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:02.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-449560QZ</udiDi>
    <basicUdiDi>B-449560QZ</basicUdiDi>
    <tradeName>Immunochemistry Systems CAL 1 Calibrator 1</tradeName>
    <deviceName>Immunochemistry Systems CAL 1 Calibrator 1</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>449560</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:02.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445814QD</udiDi>
    <basicUdiDi>B-445814QD</basicUdiDi>
    <tradeName>SYNCHRON Systems 200 ng/mL THC Urine Calibrator</tradeName>
    <deviceName>SYNCHRON Systems 200 ng/mL THC Urine Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445814</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:30.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445811Q7</udiDi>
    <basicUdiDi>B-445811Q7</basicUdiDi>
    <tradeName>SYNCHRON Systems 100 ng/mL THC Urine Calibrator</tradeName>
    <deviceName>SYNCHRON Systems 100 ng/mL THC Urine Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:29.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445809QL</udiDi>
    <basicUdiDi>B-445809QL</basicUdiDi>
    <tradeName>SYNCHRON Systems 50 ng/mL THC Urine Calibrator</tradeName>
    <deviceName>SYNCHRON Systems 50 ng/mL THC Urine Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445809</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:28.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445803Q8</udiDi>
    <basicUdiDi>B-445803Q8</basicUdiDi>
    <tradeName>SYNCHRON Systems DAT Negative Urine Calibrator</tradeName>
    <deviceName>SYNCHRON Systems DAT Negative Urine Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445803</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:26.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-441470P7</udiDi>
    <basicUdiDi>B-441470P7</basicUdiDi>
    <tradeName>Immunochemistry Systems UCAL Urine Protein Calibrator</tradeName>
    <deviceName>Immunochemistry Systems UCAL Urine Protein Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441470</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:45:32.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4280PAMMMR</udiDi>
    <basicUdiDi>B-4280PAMMMR</basicUdiDi>
    <tradeName>Antimycotic Medication Reagent Set</tradeName>
    <deviceName>Antimycotic Medication Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4280 P AMM</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:14.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4240PBZDLX</udiDi>
    <basicUdiDi>B-4240PBZDLX</basicUdiDi>
    <tradeName>Benzodiazepines Reagent Set</tradeName>
    <deviceName>Benzodiazepines Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4240 P BZD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:16:55.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4140PNTPNG</udiDi>
    <basicUdiDi>B-4140PNTPNG</basicUdiDi>
    <tradeName>Nortriptyline Reagent Set</tradeName>
    <deviceName>Nortriptyline Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4140 P NTP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:19.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4120PCZPLH</udiDi>
    <basicUdiDi>B-4120PCZPLH</basicUdiDi>
    <tradeName>Clozapine Reagent Set</tradeName>
    <deviceName>Clozapine Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4120 P CZP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:16.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4090PPS3NF</udiDi>
    <basicUdiDi>B-4090PPS3NF</basicUdiDi>
    <tradeName>Psychotropic Medication 3 Reagent Set</tradeName>
    <deviceName>Psychotropic Medication 3 Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4090 P PS3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:03.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4070PPS2MK</udiDi>
    <basicUdiDi>B-4070PPS2MK</basicUdiDi>
    <tradeName>Psychotropic Medication 2 Reagent Set</tradeName>
    <deviceName>Psychotropic Medication 2 Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4070 P PS2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:07:50.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-378045QR</udiDi>
    <basicUdiDi>B-378045QR</basicUdiDi>
    <tradeName>SYNCHRON Systems Vancomycin Calibrator</tradeName>
    <deviceName>SYNCHRON Systems Vancomycin Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152201</emdnCode>
    <emdnDescription>TDM/DRUG STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>378045</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:39.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-378020Q9</udiDi>
    <basicUdiDi>B-378020Q9</basicUdiDi>
    <tradeName>High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)</tradeName>
    <deviceName>High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>378020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:37.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>361200007G</udiDi>
    <basicUdiDi>B-361200007G</basicUdiDi>
    <tradeName>361200007G</tradeName>
    <deviceName>Referenzreihe Spez. IgE</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36120000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:33:59.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34475GW</udiDi>
    <basicUdiDi>B-34475GW</basicUdiDi>
    <tradeName>Access Toxo IgM II Calibrators</tradeName>
    <deviceName>Access Toxo IgM II Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34475</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:28:05.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34439GS</udiDi>
    <basicUdiDi>B-34439GS</basicUdiDi>
    <tradeName>Access RUBELLA IgG QC</tradeName>
    <deviceName>Access RUBELLA IgG QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34439</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:59.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34259GN</udiDi>
    <basicUdiDi>B-34259GN</basicUdiDi>
    <tradeName>Access HBc IgM QC</tradeName>
    <deviceName>Access HBc IgM QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34259</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:57.631Z</lastUpdated>
  </row>
</eudamedExport>