<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06930251802815</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 27 (867.00)(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>2026-06-26T03:39:39.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802822</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 27 (867.01)(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>2026-06-26T03:39:39.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802839</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 27 (867.03)(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>2026-06-26T03:39:39.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802846</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 27 (867.02)(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>2026-06-26T03:39:39.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802853</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 28 (867.04)(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>2026-06-26T03:39:39.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802860</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 28 (867.05)(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>2026-06-26T03:39:38.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802877</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 28 (867.07)(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>2026-06-26T03:39:38.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802884</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 28 (867.06)(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>2026-06-26T03:39:38.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802891</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 29 (866.96)(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>2026-06-26T03:39:38.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802907</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 29 (866.97)(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>2026-06-26T03:39:38.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802914</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 29 (866.98)(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>2026-06-26T03:39:38.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802921</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 29 (866.99)(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>2026-06-26T03:39:38.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802938</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>SEM 26-29 Assortment (866.88)(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>2026-06-26T03:39:38.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251802945</udiDi>
    <basicUdiDi>69302518TENS04NY</basicUdiDi>
    <tradeName>06930251802945</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>2026-06-26T03:39:38.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803041</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>KD-5923(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></emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5923</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:38.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803058</udiDi>
    <basicUdiDi>69302518BPWD02JX</basicUdiDi>
    <tradeName>MX86007(KD-7920)</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-7920</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:38.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803072</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>213-KD-5920(KD-5920B)</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-5920B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:38.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803096</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>BPST2(KD-5920B)</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-5920B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:38.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803102</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>ECO L1(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></emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>KD-5923</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:38.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803119</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>BPA-4(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></emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5923</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:39:38.695Z</lastUpdated>
  </row>
</eudamedExport>