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<eudamedExport entity="devices">
  <row>
    <udiDi>04719872743996</udiDi>
    <basicUdiDi>B-04719872743996</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName>Medical Pressure Regulator</deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120309</emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VST-359</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:20.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740261</udiDi>
    <basicUdiDi>B-04719872740261</basicUdiDi>
    <tradeName>Medical Oxygen Flowmeter Click type O2</tradeName>
    <deviceName>Medical Pressure Regulator</deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120309</emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VST-426</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:20.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872742821</udiDi>
    <basicUdiDi>471987274AC-SJXXLQ</basicUdiDi>
    <tradeName>Suction Bottle</tradeName>
    <deviceName>Suction Bottle</deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-SJ-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:16:47.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872742364</udiDi>
    <basicUdiDi>471987274AC-xx-xxLG</basicUdiDi>
    <tradeName>Inlet Adapter</tradeName>
    <deviceName>Inlet Adapter</deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SUCTION TUBING ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-CH-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:16:46.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741725</udiDi>
    <basicUdiDi>471987274AC-STXFP</basicUdiDi>
    <tradeName>Safety Trap</tradeName>
    <deviceName>Safety Trap</deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VACUUM THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-ST7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:16:45.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740049</udiDi>
    <basicUdiDi>B-04719872740049</basicUdiDi>
    <tradeName>Pulse Oximeter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-MX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740308</udiDi>
    <basicUdiDi>B-04719872740308</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSY-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740384</udiDi>
    <basicUdiDi>B-04719872740384</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VST-408</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740407</udiDi>
    <basicUdiDi>B-04719872740407</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VST-419</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741220</udiDi>
    <basicUdiDi>B-04719872741220</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSY-224</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741305</udiDi>
    <basicUdiDi>B-04719872741305</basicUdiDi>
    <tradeName>Pulse Oximeter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-TA</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741442</udiDi>
    <basicUdiDi>B-04719872741442</basicUdiDi>
    <tradeName>SpO2 Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASANR-D1</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741459</udiDi>
    <basicUdiDi>B-04719872741459</basicUdiDi>
    <tradeName>SpO2 Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASANR-F1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741572</udiDi>
    <basicUdiDi>B-04719872741572</basicUdiDi>
    <tradeName>SpO2 Probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASWNR-D3</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741701</udiDi>
    <basicUdiDi>B-04719872741701</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VST-392</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741756</udiDi>
    <basicUdiDi>B-04719872741756</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VST-312</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741787</udiDi>
    <basicUdiDi>B-04719872741787</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VST-453</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741794</udiDi>
    <basicUdiDi>B-04719872741794</basicUdiDi>
    <tradeName>Medical Pressure Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSW-220</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741848</udiDi>
    <basicUdiDi>B-04719872741848</basicUdiDi>
    <tradeName>Flowmeter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA-OB-71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741862</udiDi>
    <basicUdiDi>B-04719872741862</basicUdiDi>
    <tradeName>Flowmeter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA-OD-02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:15:36.195Z</lastUpdated>
  </row>
</eudamedExport>