<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08908003989228</udiDi>
    <basicUdiDi>8908003989nice5010L3</basicUdiDi>
    <tradeName>OxyM</tradeName>
    <deviceName>Air Oxygen Blender</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0903</emdnCode>
    <emdnDescription>CLINICAL/THERAPEUTIC APPLICATIONS GAS MIXTURES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>nice 5005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:30.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989204</udiDi>
    <basicUdiDi>8908003989nice8050M4</basicUdiDi>
    <tradeName>iSmart</tradeName>
    <deviceName>Heated (Respiratory) Humidifier</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>nice 8050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:29.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989037</udiDi>
    <basicUdiDi>8908003989nice5060LJ</basicUdiDi>
    <tradeName>OxyPAP</tradeName>
    <deviceName>Bubble CPAP System</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060202</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>nice 5060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:27.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989044</udiDi>
    <basicUdiDi>8908003989nice5060LJ</basicUdiDi>
    <tradeName>OxyPAP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060202</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>nice 5060 S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:31.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989051</udiDi>
    <basicUdiDi>8908003989nice5060LJ</basicUdiDi>
    <tradeName>OxyPAP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060202</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>nice 5060 F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:31.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989211</udiDi>
    <basicUdiDi>8908003989nice8050M4</basicUdiDi>
    <tradeName>iSmart</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>nice 8010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:30.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989235</udiDi>
    <basicUdiDi>8908003989nice5010L3</basicUdiDi>
    <tradeName>OxyM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0903</emdnCode>
    <emdnDescription>CLINICAL/THERAPEUTIC APPLICATIONS GAS MIXTURES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>nice 5010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:30.705Z</lastUpdated>
  </row>
</eudamedExport>