<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FS010-26YD</udiDi>
    <basicUdiDi>B-FS010-26YD</basicUdiDi>
    <tradeName>Allurion</tradeName>
    <deviceName>Allurion Gastric Balloon</deviceName>
    <manufacturerName>Allurion Technologies Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001377</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10D-CE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:46:52.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FD012-10QD</udiDi>
    <basicUdiDi>B-FD012-10QD</basicUdiDi>
    <tradeName>Allurion Stylet</tradeName>
    <deviceName>Allurion Stylet</deviceName>
    <manufacturerName>Allurion Technologies Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001377</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12D-CE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:18.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FD011-12QA</udiDi>
    <basicUdiDi>B-FD011-12QA</basicUdiDi>
    <tradeName>Allurion Filler Kit</tradeName>
    <deviceName>Allurion Filler Kit</deviceName>
    <manufacturerName>Allurion Technologies Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001377</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11D-CE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:18.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-10B7B</udiDi>
    <basicUdiDi>B-10B7B</basicUdiDi>
    <tradeName>Allurion Gastric Balloon System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allurion Technologies Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001377</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:46:42.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898258291089</udiDi>
    <basicUdiDi>B-07898258291089</basicUdiDi>
    <tradeName>Sterile Intragastric Balloon</tradeName>
    <deviceName>STERILE INTRAGASTRIC BALLOON</deviceName>
    <manufacturerName>Medicone Projetos e Solucoes para a Industria e a Saude Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000026420</manufacturerSrn>
    <authorisedRepresentativeName>Rápido e Contínuo Unipessoal LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000039288</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94601</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:13:57.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860005178810</udiDi>
    <basicUdiDi>B-00860005178810</basicUdiDi>
    <tradeName>Spatz3 Adjustable Balloon System</tradeName>
    <deviceName>Spatz3 Adjustable Balloon System Insertion Kit</deviceName>
    <manufacturerName>Spatz FGIA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012214</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-SP3-03K</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:54.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437025135011</udiDi>
    <basicUdiDi>84370251359092K981ME</basicUdiDi>
    <tradeName>08437025135011</tradeName>
    <deviceName>STELLA Endogastric Balloon Kit</deviceName>
    <manufacturerName>MIKROMIC MEDICAL SL</manufacturerName>
    <manufacturerSrn>ES-PR-000046348</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9092K981</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:15:00.599Z</lastUpdated>
  </row>
</eudamedExport>