<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850004725122</udiDi>
    <basicUdiDi>B-00850004725122</basicUdiDi>
    <tradeName>Deflux Metal Needle</tradeName>
    <deviceName>DEFLUX METAL NEEDLE (1 X32CM)</deviceName>
    <manufacturerName>Palette Life Sciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014009</manufacturerSrn>
    <authorisedRepresentativeName>Scandinavian Regulatory Services AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000004526</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019099</emdnCode>
    <emdnDescription>NEEDLES FOR OTHER PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX1202</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:41.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004725061</udiDi>
    <basicUdiDi>B-00850004725061</basicUdiDi>
    <tradeName>Barrigel Injectable Gel</tradeName>
    <deviceName>BARRIGEL SYRINGE (3ML)</deviceName>
    <manufacturerName>Palette Life Sciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014009</manufacturerSrn>
    <authorisedRepresentativeName>Scandinavian Regulatory Services AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000004526</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030499</emdnCode>
    <emdnDescription>RADIOTHERAPY PROTECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011507</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:25.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004725047</udiDi>
    <basicUdiDi>B-00850004725047</basicUdiDi>
    <tradeName>Deflux Gel for Injection</tradeName>
    <deviceName>DEFLUX SYRINGE (1ML)</deviceName>
    <manufacturerName>Palette Life Sciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014009</manufacturerSrn>
    <authorisedRepresentativeName>Scandinavian Regulatory Services AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000004526</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011503</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:23.133Z</lastUpdated>
  </row>
</eudamedExport>