<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10810005340158</udiDi>
    <basicUdiDi>B-10810005340158</basicUdiDi>
    <tradeName>Axonics Tined Lead (with Percutaneous Extension)</tradeName>
    <deviceName>Axonics Tined Lead (with Percutaneous Extension)</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:12.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340141</udiDi>
    <basicUdiDi>B-10810005340141</basicUdiDi>
    <tradeName>Axonics Tined Lead</tradeName>
    <deviceName>Axonics Tined Lead</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:10.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340127</udiDi>
    <basicUdiDi>B-10810005340127</basicUdiDi>
    <tradeName>Axonics PNE Lead</tradeName>
    <deviceName>Axonics PNE Lead</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:06.103Z</lastUpdated>
  </row>
</eudamedExport>