<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08436593200022</udiDi>
    <basicUdiDi>84365932000225Y</basicUdiDi>
    <tradeName>SANITY PROTECT II-AZ</tradeName>
    <deviceName>SANITY PROTECT II-AZ</deviceName>
    <manufacturerName>SANITY HEALTH S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000014604</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:54:40.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436593200015</udiDi>
    <basicUdiDi>843659320001563</basicUdiDi>
    <tradeName>SANITY PROTECT I</tradeName>
    <deviceName>SANITY PROTECT I-AZ</deviceName>
    <manufacturerName>SANITY HEALTH S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000014604</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:54:24.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436557230447</udiDi>
    <basicUdiDi>843655723NEUMOFILTPCPVQ</basicUdiDi>
    <tradeName>Neumofilt Ergo Pack Confort Plus</tradeName>
    <deviceName>Neumofilt Ergo Pack Confort Plus</deviceName>
    <manufacturerName>Medical Respiratory Devices S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000000824</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R049001</emdnCode>
    <emdnDescription>PULMONARY FUNCTION TEST FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1534N03M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:34:56.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436557230201</udiDi>
    <basicUdiDi>843655723NEUMOFILTPPSK</basicUdiDi>
    <tradeName>Neumofilt Ergo Pack Plus</tradeName>
    <deviceName>Neumofilt Ergo Pack Plus</deviceName>
    <manufacturerName>Medical Respiratory Devices S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000000824</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R049001</emdnCode>
    <emdnDescription>PULMONARY FUNCTION TEST FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1533N03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:34:53.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436557230089</udiDi>
    <basicUdiDi>843655723NEUMOFILTPCRR</basicUdiDi>
    <tradeName>Neumofilt Pack Confort</tradeName>
    <deviceName>Neumofilt Ergo Pack Confort</deviceName>
    <manufacturerName>Medical Respiratory Devices S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000000824</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R049001</emdnCode>
    <emdnDescription>PULMONARY FUNCTION TEST FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1532M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:34:52.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436557230003</udiDi>
    <basicUdiDi>843655723NEUMOFILT3G</basicUdiDi>
    <tradeName>Neumofilt Ergo</tradeName>
    <deviceName>Neumofilt Ergo</deviceName>
    <manufacturerName>Medical Respiratory Devices S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000000824</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R049001</emdnCode>
    <emdnDescription>PULMONARY FUNCTION TEST FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1532</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:34:51.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>805864740400013MW</udiDi>
    <basicUdiDi>805864740400013MW</basicUdiDi>
    <tradeName>SINUSET NASAL FILTER SMALL</tradeName>
    <deviceName>SINUSET NASAL FILTER SMALL</deviceName>
    <manufacturerName>LEM S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030387</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040299</emdnCode>
    <emdnDescription>NATURAL BREATHING FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1614836</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:50.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>805864740400006MZ</udiDi>
    <basicUdiDi>805864740400006MZ</basicUdiDi>
    <tradeName>SINUSET NASAL FILTER</tradeName>
    <deviceName>SINUSET NASAL FILTER LARGE</deviceName>
    <manufacturerName>LEM S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030387</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040299</emdnCode>
    <emdnDescription>NATURAL BREATHING FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1614841</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:44.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058647921549</udiDi>
    <basicUdiDi>805864792FTYY</basicUdiDi>
    <tradeName>08058647921549</tradeName>
    <deviceName>Antidust Filter</deviceName>
    <manufacturerName>Dima Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000020327</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT00000146</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:13:51.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056209010113</udiDi>
    <basicUdiDi>805620901svhU6</basicUdiDi>
    <tradeName>SpeVaX® - Trach-HME with Built-in Speech Valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BenCorpp Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000023046</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVH50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:06:03.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810101922</udiDi>
    <basicUdiDi>471081008NNJH92</basicUdiDi>
    <tradeName>tHME w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0071</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:17.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810101939</udiDi>
    <basicUdiDi>471081008NNJH92</basicUdiDi>
    <tradeName>tHME, 15F w/Knob</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:17.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810116445</udiDi>
    <basicUdiDi>471081008NNJH92</basicUdiDi>
    <tradeName>HME, 22F/15M, 22/15mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:52.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810117534</udiDi>
    <basicUdiDi>471081008NNJH92</basicUdiDi>
    <tradeName>nHME, 15F, 15M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:51.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540261014215</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System - ClearFlo F100 PFT Filter</tradeName>
    <deviceName>tremoflo</deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101421</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:44.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350061230050</udiDi>
    <basicUdiDi>73500612300473</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName>Adaptor</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040299</emdnCode>
    <emdnDescription>NATURAL BREATHING FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>707-2K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:02:35.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350061230305</udiDi>
    <basicUdiDi>7350061230026X</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>703-2K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:01:21.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350081780043</udiDi>
    <basicUdiDi>73500817802NT</basicUdiDi>
    <tradeName>NOSA allergy filter</tradeName>
    <deviceName>NOSA allergy filter</deviceName>
    <manufacturerName>NoseOption AB</manufacturerName>
    <manufacturerSrn>SE-MF-000025669</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20120070</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:55:21.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350047030199</udiDi>
    <basicUdiDi>735004703NIOXFILTERAW</basicUdiDi>
    <tradeName>NIOX</tradeName>
    <deviceName>NIOX Filter</deviceName>
    <manufacturerName>NIOX AB</manufacturerName>
    <manufacturerSrn>SE-MF-000010044</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R049001</emdnCode>
    <emdnDescription>PULMONARY FUNCTION TEST FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-1020</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:52:10.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>30734000671007</udiDi>
    <basicUdiDi>73400067600075</basicUdiDi>
    <tradeName>Bact-HME Basic</tradeName>
    <deviceName>Heat and Moisture Exchangers (HMEs), Bacterial/Viral Filters (BVFs), and combined HMEF devices</deviceName>
    <manufacturerName>Pharma Systems AB</manufacturerName>
    <manufacturerSrn>SE-MF-000018545</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:22:53.558Z</lastUpdated>
  </row>
</eudamedExport>