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    <tradeName>MEDICAL DRY FILM</tradeName>
    <deviceName>MEDICAL DRY FILM</deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z130106</emdnCode>
    <emdnDescription>DRY THERMAL PRINTER X-RAY FILMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:40:04.890Z</lastUpdated>
  </row>
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    <udiDi>06926349100185</udiDi>
    <basicUdiDi>69263491SDF58</basicUdiDi>
    <tradeName>MEDICAL DRY LASER FILM</tradeName>
    <deviceName>MEDICAL DRY LASER FILM</deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11079085</emdnCode>
    <emdnDescription>VARIOUS X-RAY FILM IMAGING SUPPORT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:40:04.090Z</lastUpdated>
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  <row>
    <udiDi>06958195700509</udiDi>
    <basicUdiDi>69263491SRDPYC</basicUdiDi>
    <tradeName>Medical Laser Printer SM8000</tradeName>
    <deviceName>MEDICAL LASER PRINTER</deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11079005</emdnCode>
    <emdnDescription>PRINTING MACHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58195 70050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:12:54.408Z</lastUpdated>
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    <udiDi>06958195700493</udiDi>
    <basicUdiDi>69263491SRDPYC</basicUdiDi>
    <tradeName>Medical Laser Printer SM6000</tradeName>
    <deviceName>MEDICAL LASER PRINTER</deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11079005</emdnCode>
    <emdnDescription>PRINTING MACHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58195 70049</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:12:53.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958195700486</udiDi>
    <basicUdiDi>69263491FPFJ</basicUdiDi>
    <tradeName>Dry Printer DP-X1</tradeName>
    <deviceName>MEDICAL DRY PRINTER</deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11079005</emdnCode>
    <emdnDescription>PRINTING MACHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58195 70048</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:12:47.207Z</lastUpdated>
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  <row>
    <udiDi>06926349100253</udiDi>
    <basicUdiDi>69263491SCTFWV</basicUdiDi>
    <tradeName>MEDICAL DRY FILM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z130106</emdnCode>
    <emdnDescription>DRY THERMAL PRINTER X-RAY FILMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10025</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:08:08.105Z</lastUpdated>
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    <udiDi>06926349100246</udiDi>
    <basicUdiDi>69263491SCTFWV</basicUdiDi>
    <tradeName>MEDICAL DRY FILM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z130106</emdnCode>
    <emdnDescription>DRY THERMAL PRINTER X-RAY FILMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:08:06.885Z</lastUpdated>
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    <udiDi>06926349100239</udiDi>
    <basicUdiDi>69263491SCTFWV</basicUdiDi>
    <tradeName>MEDICAL DRY FILM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z130106</emdnCode>
    <emdnDescription>DRY THERMAL PRINTER X-RAY FILMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:08:05.709Z</lastUpdated>
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  <row>
    <udiDi>06926349100215</udiDi>
    <basicUdiDi>69263491SDF58</basicUdiDi>
    <tradeName>MEDICAL DRY LASER FILM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z130101</emdnCode>
    <emdnDescription>GENERAL PURPOSE X-RAY FILMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:08:03.285Z</lastUpdated>
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    <udiDi>06926349100208</udiDi>
    <basicUdiDi>69263491SDF58</basicUdiDi>
    <tradeName>MEDICAL DRY LASER FILM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z130101</emdnCode>
    <emdnDescription>GENERAL PURPOSE X-RAY FILMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:08:02.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926349100192</udiDi>
    <basicUdiDi>69263491SDF58</basicUdiDi>
    <tradeName>MEDICAL DRY LASER FILM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Smart Health Biotech (Guangxi) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040855</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z130101</emdnCode>
    <emdnDescription>GENERAL PURPOSE X-RAY FILMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26349 10019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-23T23:08:00.880Z</lastUpdated>
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