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<eudamedExport entity="devices">
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    <udiDi>05065020725000</udiDi>
    <basicUdiDi>5065020725001RM</basicUdiDi>
    <tradeName>05065020725000</tradeName>
    <deviceName>Metadvice AI</deviceName>
    <manufacturerName>Metadvice (Suisse) SA</manufacturerName>
    <manufacturerSrn>CH-MF-000049909</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL MEDICINE INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:46:34.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060905850082</udiDi>
    <basicUdiDi>506090585AAA003S7</basicUdiDi>
    <tradeName>Glissando RS2</tradeName>
    <deviceName>Glissando RS2</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISS-RS2-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:35:13.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060905850068</udiDi>
    <basicUdiDi>506090585AAA002S5</basicUdiDi>
    <tradeName>Glissando RS20</tradeName>
    <deviceName>Glissando RS20</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISS-RS20-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:35:13.148Z</lastUpdated>
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  <row>
    <udiDi>05060905850037</udiDi>
    <basicUdiDi>506090585AAA001S3</basicUdiDi>
    <tradeName>Glissando 20SL</tradeName>
    <deviceName>Glissando 20SL Desktop Scanner</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISS-20SL-40X-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:35:12.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060905850006</udiDi>
    <basicUdiDi>506090585AAA000RZ</basicUdiDi>
    <tradeName>Glissando Desktop Scanner</tradeName>
    <deviceName>Glissando Desktop Scanner</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISSR2-40X-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:35:10.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060671730007</udiDi>
    <basicUdiDi>506067173ENDC000001RM</basicUdiDi>
    <tradeName>VC-2010</tradeName>
    <deviceName>Endoscopy Cart</deviceName>
    <manufacturerName>Endocarts International Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004309</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103320</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:30:36.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060464140266</udiDi>
    <basicUdiDi>506046414QS-ScrewdriverFM</basicUdiDi>
    <tradeName>05060464140266</tradeName>
    <deviceName>Quick-Start Screwdriver 3.5mm Hex</deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10026</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:06.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060464140259</udiDi>
    <basicUdiDi>506046414QS-GuidewireFM</basicUdiDi>
    <tradeName>Quick-Start</tradeName>
    <deviceName>Quick-Start Guidewire</deviceName>
    <manufacturerName>Innovate Orthopaedics</manufacturerName>
    <manufacturerSrn>GB-MF-000012886</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P091399</emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10025</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:06.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180058</udiDi>
    <basicUdiDi>506045618AGILITYBB</basicUdiDi>
    <tradeName>AGILITY</tradeName>
    <deviceName>AGILITY</deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:02.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180010</udiDi>
    <basicUdiDi>506045618DSXFQ</basicUdiDi>
    <tradeName>DSX Automated ELISA System with 4 incubators</tradeName>
    <deviceName>DSX Automated ELISA System</deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:02.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060456180003</udiDi>
    <basicUdiDi>506045618DS2DE</basicUdiDi>
    <tradeName>DS2 Automated ELISA System with Barcode scanner</tradeName>
    <deviceName>DS2 Automated ELISA System</deviceName>
    <manufacturerName>Dynex Technologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014753</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:01.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060045001634</udiDi>
    <basicUdiDi>5060045NCAB01CJ</basicUdiDi>
    <tradeName>Nasaleze Children's Allergy Blocker</tradeName>
    <deviceName>Nasaleze Children's Allergy Blocker</deviceName>
    <manufacturerName>Nasaleze Limited</manufacturerName>
    <manufacturerSrn>IM-MF-000004004</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCAB01</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:05:01.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060045001337</udiDi>
    <basicUdiDi>5060045NAB01HW</basicUdiDi>
    <tradeName>Nasaleze Allergy Blocker</tradeName>
    <deviceName>Nasaleze Allergy Blocker</deviceName>
    <manufacturerName>Nasaleze Limited</manufacturerName>
    <manufacturerSrn>IM-MF-000004004</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NAB01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:05:00.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060045000361</udiDi>
    <basicUdiDi>5060045NCFBP01EQ</basicUdiDi>
    <tradeName>Nasaleze Cold and Flu Blocker Plus</tradeName>
    <deviceName>Nasaleze Cold and Flu Blocker Plus</deviceName>
    <manufacturerName>Nasaleze Limited</manufacturerName>
    <manufacturerSrn>IM-MF-000004004</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NCFBP01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:04:59.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060045000354</udiDi>
    <basicUdiDi>5060045NAS01LK</basicUdiDi>
    <tradeName>Nasaleze Allergy Shield</tradeName>
    <deviceName>Nasaleze Allergy Shield</deviceName>
    <manufacturerName>Nasaleze Limited</manufacturerName>
    <manufacturerSrn>IM-MF-000004004</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NAS01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:04:58.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060045000194</udiDi>
    <basicUdiDi>5060045NCFB01DM</basicUdiDi>
    <tradeName>Nasaleze Cold and Flu Blocker</tradeName>
    <deviceName>Nasaleze Cold and Flu Blocker</deviceName>
    <manufacturerName>Nasaleze Limited</manufacturerName>
    <manufacturerSrn>IM-MF-000004004</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCFB01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:04:57.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060045000118</udiDi>
    <basicUdiDi>5060045NT01TL</basicUdiDi>
    <tradeName>Nasaleze Travel</tradeName>
    <deviceName>Nasaleze Travel</deviceName>
    <manufacturerName>Nasaleze Limited</manufacturerName>
    <manufacturerSrn>IM-MF-000004004</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:04:57.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060045000071</udiDi>
    <basicUdiDi>5060045NPMS01NA</basicUdiDi>
    <tradeName>Nasaleze PM Shield</tradeName>
    <deviceName>Nasaleze PM Shield</deviceName>
    <manufacturerName>Nasaleze Limited</manufacturerName>
    <manufacturerSrn>IM-MF-000004004</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPMS01</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:04:56.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>25060179639394</udiDi>
    <basicUdiDi>50560945SLGSHNX</basicUdiDi>
    <tradeName>Smoothline Green System Laryngoscope Handle, Adult</tradeName>
    <deviceName>Smoothline Green System Laryngoscope Handles</deviceName>
    <manufacturerName>PROACT Medical Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000006294</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12021003</emdnCode>
    <emdnDescription>LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLGSH001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:57:03.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>25060179635174</udiDi>
    <basicUdiDi>50560945MRHPCMR</basicUdiDi>
    <tradeName>MR Conditional HPC Green System Laryngoscope Blade, MAC 1</tradeName>
    <deviceName>MR Conditional HPC Green System Laryngoscope Blades</deviceName>
    <manufacturerName>PROACT Medical Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000006294</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9002</emdnCode>
    <emdnDescription>LARYNGOSCOPE BLADES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRHPCMAC1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:57:03.020Z</lastUpdated>
  </row>
</eudamedExport>