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<eudamedExport entity="devices">
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    <udiDi>08908022609084</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac 3-MEK 620H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEK-620H-HL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:48.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609091</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac-MEK 520H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEK-520H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:47.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609107</udiDi>
    <basicUdiDi>8908022609IVD0019Q</basicUdiDi>
    <tradeName>08908022609107</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEK-641H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:47.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609237</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac 710-MK-710WH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-710WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:47.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100005</udiDi>
    <basicUdiDi>08436851NKV550K7</basicUdiDi>
    <tradeName>Nihon Kohden NKV-550 Series Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-550-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100012</udiDi>
    <basicUdiDi>08436851NKV550K7</basicUdiDi>
    <tradeName>Nihon Kohden NKV-550 Series Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-550-U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100029</udiDi>
    <basicUdiDi>08436851NKV550K7</basicUdiDi>
    <tradeName>Nihon Kohden NKV-550 Series Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-550-N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100159</udiDi>
    <basicUdiDi>08436851NKV440JX</basicUdiDi>
    <tradeName>Nihon Kohden NKV-440 Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00843685100166</udiDi>
    <basicUdiDi>08436851NKV440JX</basicUdiDi>
    <tradeName>Nihon Kohden NKV-440 Ventilator System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden OrangeMed, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019023</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKV-440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:10.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851725007375</udiDi>
    <basicUdiDi>0851725007NKS-0014T</basicUdiDi>
    <tradeName>00851725007375</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden Digital Health Solutions LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042132</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:21:08.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851725007399</udiDi>
    <basicUdiDi>0851725007CNSCS-001Y7</basicUdiDi>
    <tradeName>Central Station</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nihon Kohden Digital Health Solutions LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042132</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:21:08.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>14931921902391</udiDi>
    <basicUdiDi>4931921MD10022BF</basicUdiDi>
    <tradeName>Thermal Airflow Sensor TR-190A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020485</emdnCode>
    <emdnDescription>GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P916A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:06:22.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817111021165</udiDi>
    <basicUdiDi>081711102PIEZO2M</basicUdiDi>
    <tradeName>00817111021165</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:15:37.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817111021158</udiDi>
    <basicUdiDi>081711102PIEZO2M</basicUdiDi>
    <tradeName>00817111021158</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:15:36.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817111021134</udiDi>
    <basicUdiDi>081711102RIPBC</basicUdiDi>
    <tradeName>00817111021134</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:15:35.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817111021127</udiDi>
    <basicUdiDi>081711102RIPBC</basicUdiDi>
    <tradeName>00817111021127</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:15:34.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817111021110</udiDi>
    <basicUdiDi>081711102RIPBC</basicUdiDi>
    <tradeName>00817111021110</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:11:09.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817111021103</udiDi>
    <basicUdiDi>081711102RIPBC</basicUdiDi>
    <tradeName>00817111021103</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:11:08.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817111021097</udiDi>
    <basicUdiDi>081711102THERM2W</basicUdiDi>
    <tradeName>00817111021097</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:11:07.735Z</lastUpdated>
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  <row>
    <udiDi>00817111021080</udiDi>
    <basicUdiDi>081711102THERM2W</basicUdiDi>
    <tradeName>00817111021080</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Neurotronics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000030839</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T17:11:06.656Z</lastUpdated>
  </row>
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