<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06930251803454</udiDi>
    <basicUdiDi>69302518BPMD05GX</basicUdiDi>
    <tradeName>32921(KD-558)</tradeName>
    <deviceName>Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-558</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:47.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803140</udiDi>
    <basicUdiDi>69302518PO0010CY</basicUdiDi>
    <tradeName>PC-PO 3104(PO6)</tradeName>
    <deviceName>Pulse Oximeter</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PO6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:46.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803089</udiDi>
    <basicUdiDi>69302518CUF002ED</basicUdiDi>
    <tradeName>213-KD-5920(KD-5920B) Cuff</tradeName>
    <deviceName>Blood pressure Cuff</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5920B Cuff</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:45.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802259</udiDi>
    <basicUdiDi>69302518BPMD06GZ</basicUdiDi>
    <tradeName>mHealth</tradeName>
    <deviceName>Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5815</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:45.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251800996</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>AD-2126</tradeName>
    <deviceName>Transcutaneous Electrical Nerve Stimulators (TENS Device)</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-2126</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:44.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803065</udiDi>
    <basicUdiDi>69302518EP001596</basicUdiDi>
    <tradeName>EP505036N01(EP505036N01)</tradeName>
    <deviceName>Electrode pad</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP505036N01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:42.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802334</udiDi>
    <basicUdiDi>69302518BPWD02JX</basicUdiDi>
    <tradeName>06930251802334</tradeName>
    <deviceName>Wrist Blood Pressure Monitor</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, BOXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-722  TRANSPORT BOX</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:46:41.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>03615371700243</udiDi>
    <basicUdiDi>69302518BPWD01JV</basicUdiDi>
    <tradeName>03615371700243</tradeName>
    <deviceName>Wrist Blood Pressure Monitor</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPW-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:44:31.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>03615371700236</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>03615371700236</tradeName>
    <deviceName>Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPA-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:44:30.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803324</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>33672(KD-5923)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5923</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:47:45.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803546</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>TM-ARM.003A(KD-5923)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5923</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:47:45.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>16930251800993</udiDi>
    <basicUdiDi>B-16930251800993</basicUdiDi>
    <tradeName>TENS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEUROLOGICAL STIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:21:07.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251820130</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>06930251820130</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5923</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T05:11:12.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251873846</udiDi>
    <basicUdiDi>B-06930251873846</basicUdiDi>
    <tradeName>Wrist Blood Pressure Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Wrist Blood Pressure Monitor</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T05:11:12.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251800026</udiDi>
    <basicUdiDi>B-06930251800026</basicUdiDi>
    <tradeName>Infrared Forehead Thermometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NON-CONTACT DIGITAL THERMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT2L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:39.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802341</udiDi>
    <basicUdiDi>69302518BPWD02JX</basicUdiDi>
    <tradeName>06930251802341</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, BOXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-722  TRANSPORT BOX</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:39.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802778</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 26 (866.92)(AD-2128)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-2128</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:39.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802785</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 26 (866.93)(AD-2128)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-2128</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:39.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802792</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 26 (866.94)(AD-2128)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-2128</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:39.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802808</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 26 (866.95)(AD-2128)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-2128</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:39.073Z</lastUpdated>
  </row>
</eudamedExport>