<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06941691909460</udiDi>
    <basicUdiDi>B-06941691909460</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-010-AS10</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:07:10.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909347</udiDi>
    <basicUdiDi>B-06941691909347</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-001XC-AS30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:07:05.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909330</udiDi>
    <basicUdiDi>B-06941691909330</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-001XC-AS10</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:51.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909323</udiDi>
    <basicUdiDi>B-06941691909323</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-001XN-AS30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:51.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909316</udiDi>
    <basicUdiDi>B-06941691909316</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-001XN-AS10</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:49.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909309</udiDi>
    <basicUdiDi>B-06941691909309</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-001-AS30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:45.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909293</udiDi>
    <basicUdiDi>B-06941691909293</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-001-AS10</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:44.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909156</udiDi>
    <basicUdiDi>B-06941691909156</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-148D-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:43.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909149</udiDi>
    <basicUdiDi>B-06941691909149</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-147-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:42.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909132</udiDi>
    <basicUdiDi>B-06941691909132</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-146-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:39.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909125</udiDi>
    <basicUdiDi>B-06941691909125</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-145D-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:38.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909118</udiDi>
    <basicUdiDi>B-06941691909118</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-144-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:37.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909101</udiDi>
    <basicUdiDi>B-06941691909101</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-143D-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:35.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909095</udiDi>
    <basicUdiDi>B-06941691909095</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-142-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:33.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909088</udiDi>
    <basicUdiDi>B-06941691909088</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-141-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:31.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909071</udiDi>
    <basicUdiDi>B-06941691909071</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-140-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:30.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909064</udiDi>
    <basicUdiDi>B-06941691909064</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-139-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:29.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909057</udiDi>
    <basicUdiDi>B-06941691909057</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-138RB-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:26.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909040</udiDi>
    <basicUdiDi>B-06941691909040</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-137-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:25.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691909033</udiDi>
    <basicUdiDi>B-06941691909033</basicUdiDi>
    <tradeName>Spo2 sensor</tradeName>
    <deviceName>Spo2 sensor</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-136-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:06:24.392Z</lastUpdated>
  </row>
</eudamedExport>