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    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895954</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICD-L</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:20.573Z</lastUpdated>
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    <udiDi>06970240895947</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895947</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICC-S</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:14.568Z</lastUpdated>
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    <udiDi>06970240895930</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895930</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICC-M</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:13.369Z</lastUpdated>
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    <udiDi>06970240895923</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895923</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICC-L</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:12.175Z</lastUpdated>
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    <udiDi>06970240895916</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895916</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-2</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:10.965Z</lastUpdated>
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    <udiDi>06970240895909</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895909</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-12</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:04.959Z</lastUpdated>
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    <udiDi>06970240895893</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895893</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-1</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:03.769Z</lastUpdated>
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    <udiDi>06970240895886</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895886</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-012</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:02.562Z</lastUpdated>
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    <udiDi>06970240895879</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895879</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-01</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:12:01.358Z</lastUpdated>
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    <udiDi>06970240895862</udiDi>
    <basicUdiDi>697024089SAY9</basicUdiDi>
    <tradeName>06970240895862</tradeName>
    <deviceName>Spacer for Aerosol</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0699</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-0</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:55.354Z</lastUpdated>
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    <udiDi>06970240895855</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
    <tradeName>06970240895855</tradeName>
    <deviceName>Wound Drainage System</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PDH400RPDPT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:54.153Z</lastUpdated>
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    <udiDi>06970240895848</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
    <tradeName>06970240895848</tradeName>
    <deviceName>Wound Drainage System</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDS100AFFD2DBT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:52.953Z</lastUpdated>
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    <udiDi>06970240895831</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
    <tradeName>06970240895831</tradeName>
    <deviceName>Wound Drainage System</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDS100AFFD1DBT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:51.759Z</lastUpdated>
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    <udiDi>06970240895824</udiDi>
    <basicUdiDi>697024089DTY2</basicUdiDi>
    <tradeName>06970240895824</tradeName>
    <deviceName>Drainage Tube</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFD1901T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:45.748Z</lastUpdated>
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    <udiDi>06970240895817</udiDi>
    <basicUdiDi>697024089DTY2</basicUdiDi>
    <tradeName>06970240895817</tradeName>
    <deviceName>Drainage Tube</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFD1501T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:44.551Z</lastUpdated>
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    <udiDi>06970240895800</udiDi>
    <basicUdiDi>697024089DTY2</basicUdiDi>
    <tradeName>06970240895800</tradeName>
    <deviceName>Drainage Tube</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFD1001T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:43.350Z</lastUpdated>
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    <udiDi>06970240895794</udiDi>
    <basicUdiDi>697024089OMYM-OMPL39</basicUdiDi>
    <tradeName>NORSE RESCUE Non Rebreathing Mask</tradeName>
    <deviceName>Oxygen mask</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OMPL</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:42.150Z</lastUpdated>
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    <udiDi>06970240895787</udiDi>
    <basicUdiDi>697024089OMSRT</basicUdiDi>
    <tradeName>06970240895787</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OMPSS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:36.142Z</lastUpdated>
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    <udiDi>06970240895763</udiDi>
    <basicUdiDi>697024089EBTPA</basicUdiDi>
    <tradeName>06970240895763</tradeName>
    <deviceName>Double Lumen Endobronchial Tube</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040102</emdnCode>
    <emdnDescription>ENDOBRONCHIAL OROPHARYNGEAL TUBES, RIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBT26R(DLT26R）</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:34.945Z</lastUpdated>
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    <udiDi>06970240895756</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
    <tradeName>06970240895756</tradeName>
    <deviceName>Wound Drainage System</deviceName>
    <manufacturerName>Ningbo Luke Medical Devices Co.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PDH 25ml</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:11:33.737Z</lastUpdated>
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</eudamedExport>