<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>17630055505900</udiDi>
    <basicUdiDi>76300555_025_FE</basicUdiDi>
    <tradeName>PM2 Sterilization Tray 300025</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bien-Air Surgery SA</manufacturerName>
    <manufacturerSrn>CH-MF-000016376</manufacturerSrn>
    <authorisedRepresentativeName>Bien-Air Europe Sàrl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011942</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-23T19:48:40.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>17630055505894</udiDi>
    <basicUdiDi>76300555_025_FE</basicUdiDi>
    <tradeName>PM2 Sterilization Tray Neuro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bien-Air Surgery SA</manufacturerName>
    <manufacturerSrn>CH-MF-000016376</manufacturerSrn>
    <authorisedRepresentativeName>Bien-Air Europe Sàrl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011942</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-23T19:48:39.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>17630055505887</udiDi>
    <basicUdiDi>76300555_025_FE</basicUdiDi>
    <tradeName>PM2 Sterilization Tray ENT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bien-Air Surgery SA</manufacturerName>
    <manufacturerSrn>CH-MF-000016376</manufacturerSrn>
    <authorisedRepresentativeName>Bien-Air Europe Sàrl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011942</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-23T19:48:38.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>17630055505740</udiDi>
    <basicUdiDi>76300555_025_FE</basicUdiDi>
    <tradeName>S120 Sterilization Tray</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bien-Air Surgery SA</manufacturerName>
    <manufacturerSrn>CH-MF-000016376</manufacturerSrn>
    <authorisedRepresentativeName>Bien-Air Europe Sàrl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011942</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-23T19:48:37.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>17630055505627</udiDi>
    <basicUdiDi>76300555_025_FE</basicUdiDi>
    <tradeName>OSSEOSTAP Sterilization Tray</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bien-Air Surgery SA</manufacturerName>
    <manufacturerSrn>CH-MF-000016376</manufacturerSrn>
    <authorisedRepresentativeName>Bien-Air Europe Sàrl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011942</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-23T19:48:36.256Z</lastUpdated>
  </row>
</eudamedExport>