<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945429029123</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B/L9B/ L9A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:31.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029116</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B-DC/L9B-DC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:27.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029093</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B/L9B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:26.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029109</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B-SC/L9B-SC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:25.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029086</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B-DC/L9A-DC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:21.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029079</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B-SC/L9A-SC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:18.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029062</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B/L9A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:15.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029055</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B-DC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:14.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028942</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>ND12C</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:14.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029048</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B-SC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:08.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029000</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:07.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029031</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:05.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029024</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9A-DC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:01.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028980</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>ND15S</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:26:00.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429029017</udiDi>
    <basicUdiDi>69454290SL003Q8</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>L9A-SC</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:58.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028973</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>ND15C</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:56.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028966</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>ND15A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:51.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028959</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>ND15</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:49.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028935</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>ND12A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:48.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429028928</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>ND12</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:25:45.428Z</lastUpdated>
  </row>
</eudamedExport>