<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056845200117</udiDi>
    <basicUdiDi>506012095Cat47B</basicUdiDi>
    <tradeName>Insufflation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200/48BIKBARA001/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T16:31:36.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056845200056</udiDi>
    <basicUdiDi>506012095Cat47B</basicUdiDi>
    <tradeName>Insufflation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200/25BUKBARA001/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T16:31:30.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056845200049</udiDi>
    <basicUdiDi>506012095Cat47B</basicUdiDi>
    <tradeName>Insufflation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200/01BCKZTRA001/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T16:31:29.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056845200032</udiDi>
    <basicUdiDi>506012095Cat47B</basicUdiDi>
    <tradeName>Insufflation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200/01BCKBTRA018/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T16:31:28.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056845200025</udiDi>
    <basicUdiDi>506012095Cat47B</basicUdiDi>
    <tradeName>Insufflation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200/01BCKBTRA001/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T16:31:27.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411012207</udiDi>
    <basicUdiDi>B-10704411012207</basicUdiDi>
    <tradeName>AMSure® Heat and Moisture Exchanger</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HME002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:54:15.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013037</udiDi>
    <basicUdiDi>B-10704411013037</basicUdiDi>
    <tradeName>AMSure® Heat and Moisture Exchanger</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HME001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:51:08.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791001567</udiDi>
    <basicUdiDi>7331791-HME-0-000-0002-XF</basicUdiDi>
    <tradeName>Provox Micron HME (30 pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:21.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791008375</udiDi>
    <basicUdiDi>7331791-HME-0-000-0003-XJ</basicUdiDi>
    <tradeName>Provox FreeHands HME Flow (30 pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:20.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791008955</udiDi>
    <basicUdiDi>7331791-HME-0-000-0004-XM</basicUdiDi>
    <tradeName>Freevent XtraCare Blue (30 pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7768</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:20.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791008962</udiDi>
    <basicUdiDi>7331791-HME-0-000-0004-XM</basicUdiDi>
    <tradeName>Freevent XtraCare Blue (5 pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7788</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:20.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791008979</udiDi>
    <basicUdiDi>7331791-HME-0-000-0004-XM</basicUdiDi>
    <tradeName>Freevent XtraCare White (5 pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7789</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:20.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791011405</udiDi>
    <basicUdiDi>7331791-HME-0-000-0001-XC</basicUdiDi>
    <tradeName>Provox Life Home HME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:19.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791013744</udiDi>
    <basicUdiDi>7331791-HME-0-000-0001-XC</basicUdiDi>
    <tradeName>Provox Life Energy HME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:19.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791013751</udiDi>
    <basicUdiDi>7331791-HME-0-000-0001-XC</basicUdiDi>
    <tradeName>Provox Life Protect HME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:19.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791014512</udiDi>
    <basicUdiDi>7331791-HME-0-000-0001-XC</basicUdiDi>
    <tradeName>Provox Life Night HME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8262</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:19.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791014901</udiDi>
    <basicUdiDi>7331791-HME-0-000-0004-XM</basicUdiDi>
    <tradeName>Freevent XtraCare Mini White (30 pcs)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:19.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791015618</udiDi>
    <basicUdiDi>7331791-KIT-0-000-0005-J3</basicUdiDi>
    <tradeName>Provox Life Day &amp; Night Experience Oval</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8061</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:18.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791015625</udiDi>
    <basicUdiDi>7331791-KIT-0-000-0005-J3</basicUdiDi>
    <tradeName>Provox Life Day &amp; Night Experience Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:18.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>07331791015632</udiDi>
    <basicUdiDi>7331791-KIT-0-000-0005-J3</basicUdiDi>
    <tradeName>Provox Life Day &amp; Night EXP Sensitive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atos Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8063</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:35:18.732Z</lastUpdated>
  </row>
</eudamedExport>