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<eudamedExport entity="devices">
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    <udiDi>06930251803126</udiDi>
    <basicUdiDi>69302518BPWD01JV</basicUdiDi>
    <tradeName>BPW-5(KD-738BR)</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>KD-738BR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:33.542Z</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>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5920B Cuff</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:32.752Z</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>Z12062885</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP505036N01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:31.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>06930251803041</udiDi>
    <basicUdiDi>69302518BPMD04GV</basicUdiDi>
    <tradeName>KD-5923(KD-5923)</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-5923</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:28.726Z</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>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-5815</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:26.321Z</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>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-2126</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:24.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928798621068</udiDi>
    <basicUdiDi>692879862203E</basicUdiDi>
    <tradeName>Colposcope System</tradeName>
    <deviceName>Colposcope System</deviceName>
    <manufacturerName>Xuzhou Kernel Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020694</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020703</emdnCode>
    <emdnDescription>COLPOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06928798621068</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:31.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928737885926</udiDi>
    <basicUdiDi>69287378CRVLS44</basicUdiDi>
    <tradeName>06928737885926</tradeName>
    <deviceName>Video laryngoscope (stylet)</deviceName>
    <manufacturerName>Shenzhen Coreray Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018015</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12021004</emdnCode>
    <emdnDescription>VIDEO LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-VLS</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:29.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928737860015</udiDi>
    <basicUdiDi>69287378CR31WC</basicUdiDi>
    <tradeName>06928737860015</tradeName>
    <deviceName>Video Laryngoscope</deviceName>
    <manufacturerName>Shenzhen Coreray Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018015</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12021004</emdnCode>
    <emdnDescription>VIDEO LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-31</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:26.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928737831633</udiDi>
    <basicUdiDi>69287378CR001RM</basicUdiDi>
    <tradeName>06928737831633</tradeName>
    <deviceName>SpO2 Sensor</deviceName>
    <manufacturerName>Shenzhen Coreray Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018015</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:25.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928737802879</udiDi>
    <basicUdiDi>69287378CR009S5</basicUdiDi>
    <tradeName>06928737802879</tradeName>
    <deviceName>NIBP cuff</deviceName>
    <manufacturerName>Shenzhen Coreray Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018015</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020599</emdnCode>
    <emdnDescription>NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR009</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:24.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928258000426</udiDi>
    <basicUdiDi>69282580GP900SERIES7Z</basicUdiDi>
    <tradeName>Coolite Evo</tradeName>
    <deviceName>Diode Laser System</deviceName>
    <manufacturerName>Shenzhen GSD Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002168</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040202</emdnCode>
    <emdnDescription>PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP900Q6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:18.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927155386695</udiDi>
    <basicUdiDi>69271553BONSS1446S</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>Chuck</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:19.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927155386671</udiDi>
    <basicUdiDi>69271553BONSS1436Q</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>Chuck</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:19.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927155386664</udiDi>
    <basicUdiDi>69271553BONSS1426N</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>Chuck</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:19.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927155386589</udiDi>
    <basicUdiDi>69271553BONSS1416L</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>Chuck</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:14.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927155386503</udiDi>
    <basicUdiDi>69271553BONSS0236D</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>Chuck</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:10.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927155386497</udiDi>
    <basicUdiDi>69271553BONSS1406J</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>High speed Handpiece</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:09.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927155386480</udiDi>
    <basicUdiDi>69271553BONSS1396Z</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>High speed Handpiece</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:09.051Z</lastUpdated>
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  <row>
    <udiDi>06927155386473</udiDi>
    <basicUdiDi>69271553BONSS1386X</basicUdiDi>
    <tradeName>BONSS</tradeName>
    <deviceName>High speed Handpiece</deviceName>
    <manufacturerName>Jiangsu Bonss Medical Technology Co Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023743</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010904</emdnCode>
    <emdnDescription>ENDOSCOPIC ELECTROSURGICAL UNITS (ESU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:08.870Z</lastUpdated>
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