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    <basicUdiDi>69454290LG001LL</basicUdiDi>
    <tradeName>Lower Gastrointestinal Video Endoscope</tradeName>
    <deviceName>Lower Gastrointestinal Video Endoscope</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>Z12020606</emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-A20L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:30:07.634Z</lastUpdated>
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    <udiDi>06945429061376</udiDi>
    <basicUdiDi>69454290LG001LL</basicUdiDi>
    <tradeName>Lower Gastrointestinal Video Endoscope</tradeName>
    <deviceName>Lower Gastrointestinal Video Endoscope</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>Z12020606</emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-A20</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:30:05.229Z</lastUpdated>
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    <udiDi>06945429061352</udiDi>
    <basicUdiDi>69454290EV001MG</basicUdiDi>
    <tradeName>Emergency and Transport Ventilator</tradeName>
    <deviceName>Emergency and Transport Ventilator</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>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1 Pro</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:30:01.650Z</lastUpdated>
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    <udiDi>06945429061161</udiDi>
    <basicUdiDi>69454290AX004LQ</basicUdiDi>
    <tradeName>Anesthesia machine</tradeName>
    <deviceName>Anesthesia Machine</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>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X8</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:59.999Z</lastUpdated>
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    <udiDi>06945429061154</udiDi>
    <basicUdiDi>69454290AX004LQ</basicUdiDi>
    <tradeName>Anesthesia machine</tradeName>
    <deviceName>Anesthesia Machine</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>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X6</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:58.460Z</lastUpdated>
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    <udiDi>06945429060959</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN8S HFO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:55.629Z</lastUpdated>
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    <udiDi>06945429060942</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN8</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:52.020Z</lastUpdated>
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    <udiDi>06945429060935</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN8S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:49.623Z</lastUpdated>
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    <udiDi>06945429060911</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN6S HFO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:48.471Z</lastUpdated>
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  <row>
    <udiDi>06945429060904</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN6</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:46.167Z</lastUpdated>
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  <row>
    <udiDi>06945429060898</udiDi>
    <basicUdiDi>69454290VN001RK</basicUdiDi>
    <tradeName>Neonatal and Pediatric Ventilators</tradeName>
    <deviceName>Neonatal and Pediatric Ventilators</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN6S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:42.445Z</lastUpdated>
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    <udiDi>06945429060805</udiDi>
    <basicUdiDi>69454290AC001FX</basicUdiDi>
    <tradeName>Automatic CPR Machine</tradeName>
    <deviceName>Automatic CPR Machine</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>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:40.013Z</lastUpdated>
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  <row>
    <udiDi>06945429060799</udiDi>
    <basicUdiDi>69454290AC001FX</basicUdiDi>
    <tradeName>Automatic CPR Machine</tradeName>
    <deviceName>Automatic CPR Machine</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>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:38.826Z</lastUpdated>
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    <udiDi>06945429060782</udiDi>
    <basicUdiDi>69454290AC001FX</basicUdiDi>
    <tradeName>Automatic CPR Machine</tradeName>
    <deviceName>Automatic CPR Machine</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>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:36.415Z</lastUpdated>
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    <udiDi>06945429060775</udiDi>
    <basicUdiDi>69454290AC001FX</basicUdiDi>
    <tradeName>Automatic CPR Machine</tradeName>
    <deviceName>Automatic CPR Machine</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>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES3B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:32.814Z</lastUpdated>
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    <udiDi>06945429060768</udiDi>
    <basicUdiDi>69454290AC001FX</basicUdiDi>
    <tradeName>Automatic CPR Machine</tradeName>
    <deviceName>Automatic CPR Machine</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>
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    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES3A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:32.500Z</lastUpdated>
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    <udiDi>06945429060751</udiDi>
    <basicUdiDi>69454290AC001FX</basicUdiDi>
    <tradeName>Automatic CPR Machine</tradeName>
    <deviceName>Automatic CPR Machine</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>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:29.212Z</lastUpdated>
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    <udiDi>06945429060744</udiDi>
    <basicUdiDi>69454290MS003PP</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>Z12030292</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>eCenter-CMS</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:26.818Z</lastUpdated>
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    <udiDi>06945429060430</udiDi>
    <basicUdiDi>69454290ME001LH</basicUdiDi>
    <tradeName>Medical Examination Light</tradeName>
    <deviceName>Medical Examination 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>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL10A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:23.201Z</lastUpdated>
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    <udiDi>06945429060423</udiDi>
    <basicUdiDi>69454290ME001LH</basicUdiDi>
    <tradeName>Medical Examination Light</tradeName>
    <deviceName>Medical Examination 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>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL10</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:20.818Z</lastUpdated>
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</eudamedExport>