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<eudamedExport entity="devices">
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    <udiDi>05391513879630</udiDi>
    <basicUdiDi>0539151387INST2R</basicUdiDi>
    <tradeName>EntericBio Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5070000450</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:43.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879623</udiDi>
    <basicUdiDi>B-05391513879623</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 2 plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - VP2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:42.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879616</udiDi>
    <basicUdiDi>B-05391513879616</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 1 plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - VP1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:41.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879609</udiDi>
    <basicUdiDi>B-05391513879609</basicUdiDi>
    <tradeName>EntericBio® Dx plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - GPDx</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:40.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879593</udiDi>
    <basicUdiDi>B-05391513879593</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 3 plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - VP3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:39.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879586</udiDi>
    <basicUdiDi>0539151387TIPS42</basicUdiDi>
    <tradeName>Serosep 50μl filter tips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0503020201</emdnCode>
    <emdnDescription>PIPETTE TIPS WITH FILTER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9111004.657</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:38.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879579</udiDi>
    <basicUdiDi>B-05391513879579</basicUdiDi>
    <tradeName>EntericBio® CPE plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - CPE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:37.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879562</udiDi>
    <basicUdiDi>0539151387CDIFFPY4</basicUdiDi>
    <tradeName>EntericBio® C.difficile plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - CDA</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:37.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879555</udiDi>
    <basicUdiDi>B-05391513879555</basicUdiDi>
    <tradeName>EntericBio® Gastro Panel 2 Plug-In</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - GP2A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:36.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879296</udiDi>
    <basicUdiDi>B-05391513879296</basicUdiDi>
    <tradeName>EntericBio Gastro Panel 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBGP2A-V3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:35.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879272</udiDi>
    <basicUdiDi>B-05391513879272</basicUdiDi>
    <tradeName>EntericBio ® CPE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBCPE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:34.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879265</udiDi>
    <basicUdiDi>B-05391513879265</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVP3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:33.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879258</udiDi>
    <basicUdiDi>B-05391513879258</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVP2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:32.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879241</udiDi>
    <basicUdiDi>B-05391513879241</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPVP1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:31.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879227</udiDi>
    <basicUdiDi>B-05391513879227</basicUdiDi>
    <tradeName>EntericBio® Dx plate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBGPDx-ROC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:30.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879210</udiDi>
    <basicUdiDi>B-05391513879210</basicUdiDi>
    <tradeName>EntericBio® Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBGPDx</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:29.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879166</udiDi>
    <basicUdiDi>B-05391513879166</basicUdiDi>
    <tradeName>EntericBio® Clostridioides difficile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBCDA-V2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:28.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879104</udiDi>
    <basicUdiDi>0539151387SPS7Z</basicUdiDi>
    <tradeName>EntericBio® Stool Preparation Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBSPSA-v2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:28.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513872020</udiDi>
    <basicUdiDi>0539151387HISTZN</basicUdiDi>
    <tradeName>HistoPot 10% Neutral Buffered Formalin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S10-B-FOR-60TRAY</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:27.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513872013</udiDi>
    <basicUdiDi>0539151387HISTZN</basicUdiDi>
    <tradeName>HistoPot 10% Neutral Buffered Formalin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S10-B-FOR-60ML-ASZ</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:26.216Z</lastUpdated>
  </row>
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