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<eudamedExport entity="devices">
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    <udiDi>04719872741756</udiDi>
    <basicUdiDi>B-04719872741756</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-312</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:59.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741701</udiDi>
    <basicUdiDi>B-04719872741701</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-392</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:55.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741305</udiDi>
    <basicUdiDi>B-04719872741305</basicUdiDi>
    <tradeName>Pulse Oximeter</tradeName>
    <deviceName>Pulse Oximeter</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>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-TA</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:48.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872741220</udiDi>
    <basicUdiDi>B-04719872741220</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>VSY-224</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:47.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740407</udiDi>
    <basicUdiDi>B-04719872740407</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-419</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:46.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740384</udiDi>
    <basicUdiDi>B-04719872740384</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-408</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:45.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740308</udiDi>
    <basicUdiDi>B-04719872740308</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>VSY-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:41.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872740049</udiDi>
    <basicUdiDi>B-04719872740049</basicUdiDi>
    <tradeName>Pulse Oximeter</tradeName>
    <deviceName>Pulse Oximeter</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>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-MX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:41.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872483427</udiDi>
    <basicUdiDi>B-04719872483427</basicUdiDi>
    <tradeName>Automatic Upper Arm Blood Pressure Monitor</tradeName>
    <deviceName>Automatic Upper Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Health &amp; Life Co., Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000027149</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BU 584 connect</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:40.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872483410</udiDi>
    <basicUdiDi>B-04719872483410</basicUdiDi>
    <tradeName>Automatic Upper Arm Blood Pressure Monitor</tradeName>
    <deviceName>Automatic Upper Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Health &amp; Life Co., Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000027149</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BU 580 connect</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:39.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872483403</udiDi>
    <basicUdiDi>B-04719872483403</basicUdiDi>
    <tradeName>Automatic Upper Arm Blood Pressure Monitor</tradeName>
    <deviceName>Automatic Upper Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Health &amp; Life Co., Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000027149</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BU 586 voice</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:34.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872483397</udiDi>
    <basicUdiDi>B-04719872483397</basicUdiDi>
    <tradeName>Automatic Upper Arm Blood Pressure Monitor</tradeName>
    <deviceName>Automatic Upper Arm Blood Pressure Monitor</deviceName>
    <manufacturerName>Health &amp; Life Co., Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000027149</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BU 582</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:36:33.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>04717095035218</udiDi>
    <basicUdiDi>B-04717095035218</basicUdiDi>
    <tradeName>FORA PO200</tradeName>
    <deviceName>FORA PO200 Fingertip Pulse Oximeter</deviceName>
    <manufacturerName>TaiDoc Technology Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000017956</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-8255</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:57:02.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980991</udiDi>
    <basicUdiDi>B-04713072980991</basicUdiDi>
    <tradeName>SPENGLER</tradeName>
    <deviceName>Pulse oximeter</deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5012731509</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:50:06.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980977</udiDi>
    <basicUdiDi>B-04713072980977</basicUdiDi>
    <tradeName>SPENGLER</tradeName>
    <deviceName>Pulse oximeter</deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5012731509</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:50:04.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980953</udiDi>
    <basicUdiDi>B-04713072980953</basicUdiDi>
    <tradeName>SPENGLER</tradeName>
    <deviceName>Pulse oximeter</deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5012731509</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:50:02.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072980939</udiDi>
    <basicUdiDi>B-04713072980939</basicUdiDi>
    <tradeName>Aposán</tradeName>
    <deviceName>Fingertip Pulse Oximeter</deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5012733410 &amp; 5012733510</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:50:00.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712826095066</udiDi>
    <basicUdiDi>B-04712826095066</basicUdiDi>
    <tradeName>Rossmax</tradeName>
    <deviceName>Fingertip Pulse Oximeter</deviceName>
    <manufacturerName>Rossmax Innotek Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000013317</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB100</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:58.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712826095028</udiDi>
    <basicUdiDi>B-04712826095028</basicUdiDi>
    <tradeName>RESQ-METER</tradeName>
    <deviceName>Fingertip Pulse Oximeter</deviceName>
    <manufacturerName>Rossmax Innotek Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000013317</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA6SB200000000032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:56.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712826092058</udiDi>
    <basicUdiDi>B-04712826092058</basicUdiDi>
    <tradeName>Rossmax</tradeName>
    <deviceName>Fingertip Pulse Oximeter</deviceName>
    <manufacturerName>Rossmax Innotek Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000013317</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD100</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:55.855Z</lastUpdated>
  </row>
</eudamedExport>