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    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
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    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-24T22:20:14.302Z</lastUpdated>
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    <tradeName>Specialized Fetal &amp; Maternal Monitor</tradeName>
    <deviceName></deviceName>
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    <udiDi>06945429020632</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C21</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:14.155Z</lastUpdated>
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    <udiDi>06945429020649</udiDi>
    <basicUdiDi>69454290FM001KU</basicUdiDi>
    <tradeName>Specialized Fetal &amp; Maternal Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C21A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:14.101Z</lastUpdated>
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    <udiDi>06945429020656</udiDi>
    <basicUdiDi>69454290FM001KU</basicUdiDi>
    <tradeName>Specialized Fetal &amp; Maternal Monitor</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:14.047Z</lastUpdated>
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    <tradeName>Specialized Fetal &amp; Maternal Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:13.997Z</lastUpdated>
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    <udiDi>06945429020717</udiDi>
    <basicUdiDi>69454290SM001QB</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC3A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:13.891Z</lastUpdated>
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    <udiDi>06945429020724</udiDi>
    <basicUdiDi>69454290SM001QB</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC3B</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:13.836Z</lastUpdated>
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    <udiDi>06945429020731</udiDi>
    <basicUdiDi>69454290SM001QB</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPUS i3</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:13.785Z</lastUpdated>
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    <udiDi>06945429020748</udiDi>
    <basicUdiDi>69454290SM001QB</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC5A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:13.728Z</lastUpdated>
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    <udiDi>06945429020755</udiDi>
    <basicUdiDi>69454290SM001QB</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC5</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:20:13.677Z</lastUpdated>
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    <basicUdiDi>B-00732094250282</basicUdiDi>
    <tradeName>Welch Allyn Connex Vital Signs Monitor</tradeName>
    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NXDX-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:41:29.479Z</lastUpdated>
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    <tradeName>Welch Allyn Connex Vital Signs Monitor</tradeName>
    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
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    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NCDX-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:41:25.474Z</lastUpdated>
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    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
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    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NCDX</reference>
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    <lastUpdated>2026-07-22T03:41:24.674Z</lastUpdated>
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    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
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    <emdnCode>Z1203020201</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NXDX</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:41:23.875Z</lastUpdated>
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    <tradeName>Welch Allyn Connex Vital Signs Monitor</tradeName>
    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
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    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NCDX-6</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:41:23.079Z</lastUpdated>
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    <tradeName>Welch Allyn Connex Vital Signs Monitor</tradeName>
    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NXDX-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:41:19.416Z</lastUpdated>
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    <tradeName>Welch Allyn Connex Vital Signs Monitor</tradeName>
    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NCDX-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:41:18.278Z</lastUpdated>
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    <tradeName>Welch Allyn Connex Vital Signs Monitor</tradeName>
    <deviceName>VITAL SIGNS MONITOR</deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67NXDX-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:41:17.473Z</lastUpdated>
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