<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ZSI475FTM-L210GY</udiDi>
    <basicUdiDi>B-ZSI475FTM-L210GY</basicUdiDi>
    <tradeName>ZSI 475 FTM L210 - penile implant and accessories</tradeName>
    <deviceName>penile implant and accessories</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 475 FTM L210</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:23.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI475FTM-L180HG</udiDi>
    <basicUdiDi>B-ZSI475FTM-L180HG</basicUdiDi>
    <tradeName>ZSI 475 FTM L180 - penile implant and accessories</tradeName>
    <deviceName>penile implant and accessories</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 475 FTM L180</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:19.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI475FTM-L120GW</udiDi>
    <basicUdiDi>B-ZSI475FTM-L120GW</basicUdiDi>
    <tradeName>ZSI 475 FTM L120 - penile implant and accessories</tradeName>
    <deviceName>penile implant and accessories</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 475 FTM L120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:18.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI375-PFHT</udiDi>
    <basicUdiDi>B-ZSI375-PFHT</basicUdiDi>
    <tradeName>ZSI 375 PF - Artificial urinary sphincter and accessories</tradeName>
    <deviceName>Artificial urinary sphincter and accessories</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080102</emdnCode>
    <emdnDescription>ARTIFICIAL URINARY SPHINCTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 375 PF</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:17.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100FTM-D13UY</udiDi>
    <basicUdiDi>B-ZSI100FTM-D13UY</basicUdiDi>
    <tradeName>ZSI 100 FTM D13 - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 FTM D13</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:16.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-D9BM</udiDi>
    <basicUdiDi>B-ZSI100-D9BM</basicUdiDi>
    <tradeName>ZSI 100 D9 - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 D4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:12.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-D4BB</udiDi>
    <basicUdiDi>B-ZSI100-D4BB</basicUdiDi>
    <tradeName>ZSI 100 D4 - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 D4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:11.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-FTMAU</udiDi>
    <basicUdiDi>B-ZSI100-FTMAU</basicUdiDi>
    <tradeName>ZSI 100 FTM - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 FTM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:11.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-D9CF3E</udiDi>
    <basicUdiDi>B-ZSI100-D9CF3E</basicUdiDi>
    <tradeName>ZSI 100 D9 CF - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 D9 CF</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:14:10.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-D13CF2F</udiDi>
    <basicUdiDi>B-ZSI100-D13CF2F</basicUdiDi>
    <tradeName>ZSI 100 D13 CF - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 D13 CF</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:13:53.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-D135S</udiDi>
    <basicUdiDi>B-ZSI100-D135S</basicUdiDi>
    <tradeName>ZSI 100 D13 - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 D13</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:13:52.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-D11CF25</udiDi>
    <basicUdiDi>B-ZSI100-D11CF25</basicUdiDi>
    <tradeName>ZSI 100 D11 CF - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 D11 CF</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:13:51.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI100-D115N</udiDi>
    <basicUdiDi>B-ZSI100-D115N</basicUdiDi>
    <tradeName>ZSI 100 D11 - Malleable penile implant</tradeName>
    <deviceName>Malleable penile implant</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI 100 D11</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:13:50.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZSI475MY</udiDi>
    <basicUdiDi>B-ZSI475MY</basicUdiDi>
    <tradeName>ZSI475 - penile implant and accessories</tradeName>
    <deviceName>Penile implant and accesories</deviceName>
    <manufacturerName>Zephyr Surgical Implants sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000026382</manufacturerSrn>
    <authorisedRepresentativeName>ZEPHYR SURGICAL IMPLANTS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000816</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZSI475</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:35:59.627Z</lastUpdated>
  </row>
</eudamedExport>