<?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>08908003989754</udiDi>
    <basicUdiDi>08908003989PI6P</basicUdiDi>
    <tradeName>08908003989754</tradeName>
    <deviceName>Patient Interfaces</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nasal cannula, Nasal prongs ,Nasal mask , Nasal T bar prongs ,Resuscitation face mask and Flow tube</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:24.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989495</udiDi>
    <basicUdiDi>08908003989BC4Z</basicUdiDi>
    <tradeName>BC 510 BC 555 BC 525 BC 530 BC 570 BC 575 BC 515 BC 535 BC 520 BC 540 BC 545 BC 550 BC 580 BC 585 BC 630 BC 610 BC 615 BC 620 BC 625 BC 635 BC 640 BC 645 BC 650 BC 710 BC 715 BC 720 BC 725 BC 730  BC 735 BC 740 BC 745 50-05-154 50-05-150</tradeName>
    <deviceName>Breathing Circuits</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>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:23.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989310</udiDi>
    <basicUdiDi>08908003989MARSYJ</basicUdiDi>
    <tradeName>MARS</tradeName>
    <deviceName>Medical Air Compressor</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>V0903</emdnCode>
    <emdnDescription>CLINICAL/THERAPEUTIC APPLICATIONS GAS MIXTURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:22.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989242</udiDi>
    <basicUdiDi>08908003989Hornpuff54</basicUdiDi>
    <tradeName>Horn puff</tradeName>
    <deviceName>Infant T-piece Resuscitator with Accessories</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:16.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989198</udiDi>
    <basicUdiDi>08908003989Operah7Z</basicUdiDi>
    <tradeName>Operah</tradeName>
    <deviceName>Infant Radiant Warmer with accessories</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>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 2007 S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:15.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989136</udiDi>
    <basicUdiDi>08908003989Orchid77</basicUdiDi>
    <tradeName>Orchid</tradeName>
    <deviceName>Infant Transport Incubator with Accessories</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>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 3000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:14.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989112</udiDi>
    <basicUdiDi>08908003989WallabyY5</basicUdiDi>
    <tradeName>Wallaby</tradeName>
    <deviceName>Infant Incubator with Accessories</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>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 3010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:12.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989075</udiDi>
    <basicUdiDi>08908003989OperahplusTW</basicUdiDi>
    <tradeName>Operah plus</tradeName>
    <deviceName>Infant Radiant Warmer with T-piece Resuscitator, Phototherapy and Accessories</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>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5000 RP</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:06.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989006</udiDi>
    <basicUdiDi>08908003989SapphireZE</basicUdiDi>
    <tradeName>Sapphire</tradeName>
    <deviceName>Infant Phototherapy with Accessories</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>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 4000 LED</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:08:05.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989013</udiDi>
    <basicUdiDi>08908003989SapphireZE</basicUdiDi>
    <tradeName>Seefar</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>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 4000 SPOT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:31.213Z</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>08908003989068</udiDi>
    <basicUdiDi>B-08908003989068</basicUdiDi>
    <tradeName>Operah Plus</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5000 R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:31.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989082</udiDi>
    <basicUdiDi>B-08908003989082</basicUdiDi>
    <tradeName>Operah Plus</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5000 P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:31.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989099</udiDi>
    <basicUdiDi>B-08908003989099</basicUdiDi>
    <tradeName>Operah</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:31.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989105</udiDi>
    <basicUdiDi>B-08908003989105</basicUdiDi>
    <tradeName>Wallaby</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 3010 H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:30.978Z</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>
</eudamedExport>