<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>16970384237068</udiDi>
    <basicUdiDi>697038423K2GNY</basicUdiDi>
    <tradeName>FISIO CHAMBER VISION Anti-static inahaler chamber with Vision Valve for MDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0680</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-1020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-09-23T09:06:08.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233015</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composition : valve, 9 resistors and “T” connector with tube for the connection with the manometer (not included)</tradeName>
    <deviceName>BREATHING EXERCISERS</deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-09-23T08:45:51.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384237297</udiDi>
    <basicUdiDi>697038423K2GNY</basicUdiDi>
    <tradeName>FISIO CHAMBER TRIGON Anti-static inhaler chamber for MDI with new vision valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0680</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-1040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T18:06:38.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384237174</udiDi>
    <basicUdiDi>697038423K2GNY</basicUdiDi>
    <tradeName>FISIO CHAMBER TRIGON Anti-static inhaler chamber for MDI with new Panda mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0680</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-1031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:37:04.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384237181</udiDi>
    <basicUdiDi>697038423K2GNY</basicUdiDi>
    <tradeName>FISIO CHAMBER TRIGON Anti-static inhaler chamber for MDI with new Panda mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0680</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-1032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:37:02.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384237303</udiDi>
    <basicUdiDi>697038423K2GNY</basicUdiDi>
    <tradeName>FISIO CHAMBER TRIGON Anti-static inhaler chamber for MDI with Fisio mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0680</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-1043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:37:01.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233121</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composition: valve, 9 resistors and “T” connector with tube for the connection with the manometer (not included), mouthpiece and carrying bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803HC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:36:39.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233091</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composed: valve, 9 resistors and “T” connector with tube for the connection with the manometer (not included), infant silicone mask and carrying bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803HCI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:36:19.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233107</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composed: valve, 9 resistors and “T” connector with tube for the connection with the manometer (not included), infant silicone mask and carrying bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803HCO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:36:19.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233138</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composed: valve, 9 resistors and “T” connector with tube for the connection with the manometer (not included), infant silicone mask and carrying bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:36:18.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233145</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composed: valve, 9 resistors and “T” connector with tube for the connection with the manometer (not included), pediatric silicone mask and carrying bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803HCP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:41.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233152</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composed: valve, 9 resistors and “T” connector with tube for the connection with the manometer (not included), adult silicone mask and carrying bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803HCA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:35.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233114</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Kit composed: valve, 10 resistors and “T” connector with tube for the connection with the manometer (not included), Extra Large silicone mask and carrying bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803HCL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:18.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233060</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Silicone mask newborn 0 size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-8045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:18.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233053</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Silicone mask newborn 1  size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-8044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:18.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233206</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Silicone mask infant size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-8043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:18.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233190</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Silicone mask pediatric size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-8042</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:17.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233183</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Silicone mask adult size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-8041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:16.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233176</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Silicone mask extra -large size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-8040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:15.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970384233312</udiDi>
    <basicUdiDi>697038423K2CNQ</basicUdiDi>
    <tradeName>Resistor set 1,5 mm diameter, black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOO (SHANGHAI) INDUSTRIES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000045584</manufacturerSrn>
    <authorisedRepresentativeName>KOO EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000030005</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150199</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM-803D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:35:15.729Z</lastUpdated>
  </row>
</eudamedExport>