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    <tradeName>06970240891840</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>SDS100FFD1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:19.177Z</lastUpdated>
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    <udiDi>06970240891833</udiDi>
    <basicUdiDi>697024089NMYJ</basicUdiDi>
    <tradeName>06970240891833</tradeName>
    <deviceName>Nebulizer 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NMXLA</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:17.995Z</lastUpdated>
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    <udiDi>06970240891826</udiDi>
    <basicUdiDi>697024089NMYJ</basicUdiDi>
    <tradeName>06970240891826</tradeName>
    <deviceName>Nebulizer 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NMSA</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:11.974Z</lastUpdated>
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    <udiDi>06970240891819</udiDi>
    <basicUdiDi>697024089NMYJ</basicUdiDi>
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    <deviceName>Nebulizer 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NMXSA</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:10.771Z</lastUpdated>
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    <udiDi>06970240891802</udiDi>
    <basicUdiDi>697024089OMYM-OMPS3P</basicUdiDi>
    <tradeName>06970240891802</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>OMPS</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:09.574Z</lastUpdated>
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    <udiDi>06970240891796</udiDi>
    <basicUdiDi>697024089TTZJ</basicUdiDi>
    <tradeName>06970240891796</tradeName>
    <deviceName>Tracheostomy 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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT090PC</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:08.370Z</lastUpdated>
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    <udiDi>06970240891789</udiDi>
    <basicUdiDi>697024089TTZJ</basicUdiDi>
    <tradeName>06970240891789</tradeName>
    <deviceName>Tracheostomy 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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT050PC</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:02.366Z</lastUpdated>
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    <udiDi>06970240891772</udiDi>
    <basicUdiDi>697024089TTZJ</basicUdiDi>
    <tradeName>06970240891772</tradeName>
    <deviceName>Tracheostomy 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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT090P</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:55:01.164Z</lastUpdated>
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    <udiDi>06970240891765</udiDi>
    <basicUdiDi>697024089TTZJ</basicUdiDi>
    <tradeName>06970240891765</tradeName>
    <deviceName>Tracheostomy 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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT030P</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:59.965Z</lastUpdated>
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    <udiDi>06970240891727</udiDi>
    <basicUdiDi>697024089NMYJ</basicUdiDi>
    <tradeName>06970240891727</tradeName>
    <deviceName>Nebulizer 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NMMA</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:58.763Z</lastUpdated>
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    <udiDi>06970240891710</udiDi>
    <basicUdiDi>697024089NMYJ</basicUdiDi>
    <tradeName>06970240891710</tradeName>
    <deviceName>Nebulizer 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NMLA</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:52.757Z</lastUpdated>
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    <udiDi>06970240891697</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
    <tradeName>06970240891697</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>SDS400RFD19DBT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:51.567Z</lastUpdated>
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    <udiDi>06970240891680</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
    <tradeName>06970240891680</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>SDS200RPD18DBT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:50.370Z</lastUpdated>
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    <udiDi>06970240891673</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
    <tradeName>06970240891673</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>SDS200RPD14DBT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:49.152Z</lastUpdated>
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    <udiDi>06970240891666</udiDi>
    <basicUdiDi>697024089WDSS8</basicUdiDi>
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    <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>SDS200RPDP14DBT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:43.150Z</lastUpdated>
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    <udiDi>06970240891581</udiDi>
    <basicUdiDi>697024089VLZ8</basicUdiDi>
    <tradeName>Luke Vessel loop</tradeName>
    <deviceName>Vessel loop</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>H030199</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS FOR OPEN SURGERY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPA02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:41.948Z</lastUpdated>
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    <udiDi>06970240891574</udiDi>
    <basicUdiDi>697024089DTY2</basicUdiDi>
    <tradeName>06970240891574</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>TDT32</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:40.750Z</lastUpdated>
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    <udiDi>06970240891567</udiDi>
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    <tradeName>06970240891567</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>TDT30</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:39.545Z</lastUpdated>
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    <tradeName>06970240891550</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>TDT14</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:33.542Z</lastUpdated>
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    <udiDi>06970240891543</udiDi>
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    <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>RFD10T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:54:32.354Z</lastUpdated>
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