<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00852184003526</udiDi>
    <basicUdiDi>B-00852184003526</basicUdiDi>
    <tradeName>TransAeris System</tradeName>
    <deviceName>TransAeris System</deviceName>
    <manufacturerName>Synapse Biomedical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029893</manufacturerSrn>
    <authorisedRepresentativeName>SYNAPSE BIOMEDICAL EUROPE S.A.R.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000025698</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12062780</emdnCode>
    <emdnDescription>FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-1000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:22:41.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852184003205</udiDi>
    <basicUdiDi>B-00852184003205</basicUdiDi>
    <tradeName>NeuRx Diaphragm Pacing System</tradeName>
    <deviceName>NeuRx Diaphragm Pacing System</deviceName>
    <manufacturerName>Synapse Biomedical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029893</manufacturerSrn>
    <authorisedRepresentativeName>SYNAPSE BIOMEDICAL EUROPE S.A.R.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000025698</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12062780</emdnCode>
    <emdnDescription>FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-0000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:22:40.955Z</lastUpdated>
  </row>
</eudamedExport>