<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06941691907190</udiDi>
    <basicUdiDi>B-06941691907190</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-AF10</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:01:14.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691907176</udiDi>
    <basicUdiDi>B-06941691907176</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-AF10</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:01:10.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941691907169</udiDi>
    <basicUdiDi>B-06941691907169</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-AF30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:01:10.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973437866</udiDi>
    <basicUdiDi>B-06931973437866</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C110-61D</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:20.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973437057</udiDi>
    <basicUdiDi>B-06931973437057</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C103-01X</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:19.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973437040</udiDi>
    <basicUdiDi>B-06931973437040</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C410-155DX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:18.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973437033</udiDi>
    <basicUdiDi>B-06931973437033</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C403-153R</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:18.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973437026</udiDi>
    <basicUdiDi>B-06931973437026</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C410-91</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:14.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973437019</udiDi>
    <basicUdiDi>B-06931973437019</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C403-08</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:13.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973437002</udiDi>
    <basicUdiDi>B-06931973437002</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C410-29</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:12.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436999</udiDi>
    <basicUdiDi>B-06931973436999</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C410-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:11.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436975</udiDi>
    <basicUdiDi>B-06931973436975</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C910-01X</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:07.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436937</udiDi>
    <basicUdiDi>B-06931973436937</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C410B-293</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:06.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436920</udiDi>
    <basicUdiDi>B-06931973436920</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C410F-205D</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:06.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436944</udiDi>
    <basicUdiDi>B-06931973436944</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C310-206</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:05.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436821</udiDi>
    <basicUdiDi>B-06931973436821</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C410F-65D</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:02:11.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436814</udiDi>
    <basicUdiDi>B-06931973436814</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C110-96</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:02:10.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436753</udiDi>
    <basicUdiDi>B-06931973436753</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C110F-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:02:09.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436746</udiDi>
    <basicUdiDi>B-06931973436746</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C523-153R</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:02:09.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931973436739</udiDi>
    <basicUdiDi>B-06931973436739</basicUdiDi>
    <tradeName>SZcaremed</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Caremed Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C543-01AX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:01:53.748Z</lastUpdated>
  </row>
</eudamedExport>