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    <basicUdiDi>69454290PM013PH</basicUdiDi>
    <tradeName>Multi-parameter patient monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>ND10S</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:40.760Z</lastUpdated>
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    <udiDi>06945429028904</udiDi>
    <basicUdiDi>69454290PM013PH</basicUdiDi>
    <tradeName>Multi-parameter patient monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>ND10C</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:39.658Z</lastUpdated>
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    <udiDi>06945429028898</udiDi>
    <basicUdiDi>69454290PM013PH</basicUdiDi>
    <tradeName>Multi-parameter patient monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>ND10A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:37.172Z</lastUpdated>
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    <udiDi>06945429028881</udiDi>
    <basicUdiDi>69454290PM013PH</basicUdiDi>
    <tradeName>Multi-parameter patient monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>ND10</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:33.589Z</lastUpdated>
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    <udiDi>06945429028874</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC7Neo</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:32.667Z</lastUpdated>
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    <udiDi>06945429028867</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC7C</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:29.985Z</lastUpdated>
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    <udiDi>06945429028843</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC7</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:28.990Z</lastUpdated>
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    <udiDi>06945429028850</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC7A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:24.448Z</lastUpdated>
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    <udiDi>06945429028812</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC6A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:22.748Z</lastUpdated>
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    <udiDi>06945429028836</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC6Neo</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:21.840Z</lastUpdated>
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    <udiDi>06945429028829</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC6C</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:19.226Z</lastUpdated>
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    <udiDi>06945429028805</udiDi>
    <basicUdiDi>69454290SM002QD</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs 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>NC6</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:17.622Z</lastUpdated>
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    <udiDi>06945429028751</udiDi>
    <basicUdiDi>69454290VE004PS</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-2010C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:11.206Z</lastUpdated>
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    <udiDi>06945429028768</udiDi>
    <basicUdiDi>69454290VE004PS</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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    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELS-2010U</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:10.969Z</lastUpdated>
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  <row>
    <udiDi>06945429028744</udiDi>
    <basicUdiDi>69454290VE004PS</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>
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    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELS-2000U</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:08.345Z</lastUpdated>
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    <udiDi>06945429028737</udiDi>
    <basicUdiDi>69454290VE004PS</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>
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    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELS-2000C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:07.146Z</lastUpdated>
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    <udiDi>06945429028676</udiDi>
    <basicUdiDi>69454290VE003PQ</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-2000U</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:01.146Z</lastUpdated>
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    <udiDi>06945429028706</udiDi>
    <basicUdiDi>69454290VE003PQ</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIS-2000E</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:59.963Z</lastUpdated>
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    <udiDi>06945429028720</udiDi>
    <basicUdiDi>69454290VE003PQ</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-2000X</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:58.747Z</lastUpdated>
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    <udiDi>06945429028713</udiDi>
    <basicUdiDi>69454290VE003PQ</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIS-2000S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:24:57.559Z</lastUpdated>
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