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    <tradeName>Medical Endoscopic Video Processor</tradeName>
    <deviceName>Medical Endoscopic Video Processor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIS-1000U</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:34.928Z</lastUpdated>
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    <udiDi>06945429062588</udiDi>
    <basicUdiDi>69454290VE014PV</basicUdiDi>
    <tradeName>Medical Endoscopic Light Source</tradeName>
    <deviceName>Medical Endoscopic Light Source</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020402</emdnCode>
    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELS-1500C</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:29.320Z</lastUpdated>
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    <udiDi>06945429062571</udiDi>
    <basicUdiDi>69454290VE014PV</basicUdiDi>
    <tradeName>Medical Endoscopic Light Source</tradeName>
    <deviceName>Medical Endoscopic Light Source</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020402</emdnCode>
    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELS-1500U</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:25.717Z</lastUpdated>
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    <udiDi>06945429062564</udiDi>
    <basicUdiDi>69454290VE015PX</basicUdiDi>
    <tradeName>Medical Endoscopic Video Processor</tradeName>
    <deviceName>Medical Endoscopic Video Processor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIS-1500E</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:23.316Z</lastUpdated>
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    <udiDi>06945429062557</udiDi>
    <basicUdiDi>69454290VE015PX</basicUdiDi>
    <tradeName>Medical Endoscopic Video Processor</tradeName>
    <deviceName>Medical Endoscopic Video Processor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIS-1500X</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:22.123Z</lastUpdated>
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    <udiDi>06945429062540</udiDi>
    <basicUdiDi>69454290VE015PX</basicUdiDi>
    <tradeName>Medical Endoscopic Video Processor</tradeName>
    <deviceName>Medical Endoscopic Video Processor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIS-1500Pro</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:19.717Z</lastUpdated>
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    <udiDi>06945429062533</udiDi>
    <basicUdiDi>69454290VE015PX</basicUdiDi>
    <tradeName>Medical Endoscopic Video Processor</tradeName>
    <deviceName>Medical Endoscopic Video Processor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIS-1500U</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:16.115Z</lastUpdated>
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    <udiDi>06945429062458</udiDi>
    <basicUdiDi>69454290FM003KY</basicUdiDi>
    <tradeName>Specialized Fetal&amp;Maternal Monitor</tradeName>
    <deviceName>Specialized Fetal &amp; Maternal Monitor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF30A R</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:13.714Z</lastUpdated>
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    <udiDi>06945429062441</udiDi>
    <basicUdiDi>69454290FM003KY</basicUdiDi>
    <tradeName>Specialized Fetal&amp;Maternal Monitor</tradeName>
    <deviceName>Specialized Fetal &amp; Maternal Monitor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF30A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:12.509Z</lastUpdated>
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    <udiDi>06945429062434</udiDi>
    <basicUdiDi>69454290FM003KY</basicUdiDi>
    <tradeName>Specialized Fetal&amp;Maternal Monitor</tradeName>
    <deviceName>Specialized Fetal &amp; Maternal Monitor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF30 R</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:10.106Z</lastUpdated>
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  <row>
    <udiDi>06945429062427</udiDi>
    <basicUdiDi>69454290FM003KY</basicUdiDi>
    <tradeName>Specialized Fetal&amp;Maternal Monitor</tradeName>
    <deviceName>Specialized Fetal &amp; Maternal Monitor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF30</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:06.500Z</lastUpdated>
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  <row>
    <udiDi>06945429062410</udiDi>
    <basicUdiDi>69454290FM003KY</basicUdiDi>
    <tradeName>Specialized Fetal &amp; Maternal Monitor</tradeName>
    <deviceName>Specialized Fetal &amp; Maternal Monitor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF3A R</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:04.104Z</lastUpdated>
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  <row>
    <udiDi>06945429062403</udiDi>
    <basicUdiDi>69454290FM003KY</basicUdiDi>
    <tradeName>Specialized Fetal &amp; Maternal Monitor</tradeName>
    <deviceName>Specialized Fetal &amp; Maternal Monitor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF3A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:02.901Z</lastUpdated>
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  <row>
    <udiDi>06945429062380</udiDi>
    <basicUdiDi>69454290FM003KY</basicUdiDi>
    <tradeName>Specialized Fetal &amp; Maternal Monitor</tradeName>
    <deviceName>Specialized Fetal &amp; Maternal Monitor</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF3</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:32:00.506Z</lastUpdated>
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  <row>
    <udiDi>06945429062373</udiDi>
    <basicUdiDi>69454290MS005PT</basicUdiDi>
    <tradeName>Central Monitoring System Software</tradeName>
    <deviceName>Central Monitoring System Software</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030201</emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>eCenter-OB</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:31:56.896Z</lastUpdated>
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    <udiDi>06945429062366</udiDi>
    <basicUdiDi>69454290SL004QA</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED Surgical Light</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L8A/L8A/L7</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:31:54.495Z</lastUpdated>
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    <udiDi>06945429062359</udiDi>
    <basicUdiDi>69454290SL004QA</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED Surgical Light</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L8B/L8B/L7</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:31:53.302Z</lastUpdated>
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    <udiDi>06945429062342</udiDi>
    <basicUdiDi>69454290SL004QA</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED Surgical Light</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L8B/L8B/L8A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:31:50.900Z</lastUpdated>
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    <udiDi>06945429062335</udiDi>
    <basicUdiDi>69454290SL004QA</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED Surgical Light</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L7-QC/L7-QC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:31:47.289Z</lastUpdated>
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    <udiDi>06945429062328</udiDi>
    <basicUdiDi>69454290SL004QA</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED Surgical Light</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L7-DC/L7-DC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:31:44.916Z</lastUpdated>
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</eudamedExport>