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    <tradeName>00817136026978</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115216</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:52.022Z</lastUpdated>
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    <udiDi>00817136026985</udiDi>
    <basicUdiDi>081713602691312BD</basicUdiDi>
    <tradeName>00817136026985</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115217</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:52.001Z</lastUpdated>
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    <udiDi>00817136026992</udiDi>
    <basicUdiDi>081713602691312BD</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115218</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:17:51.980Z</lastUpdated>
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    <udiDi>06974269382358</udiDi>
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    <tradeName>BM</tradeName>
    <deviceName>Oxygen mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0408</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:22.948Z</lastUpdated>
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    <udiDi>06974269382341</udiDi>
    <basicUdiDi>B-06974269382341</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>oxygen mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0407</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:21.341Z</lastUpdated>
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    <udiDi>06974269382334</udiDi>
    <basicUdiDi>B-06974269382334</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>oxygen mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0406</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:20.524Z</lastUpdated>
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    <udiDi>06974269382327</udiDi>
    <basicUdiDi>B-06974269382327</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>oxygen mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0405</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:18.918Z</lastUpdated>
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    <udiDi>06974269382068</udiDi>
    <basicUdiDi>B-06974269382068</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>Oxygen mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:26.874Z</lastUpdated>
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    <udiDi>06974269382051</udiDi>
    <basicUdiDi>B-06974269382051</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>Oxygen mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0403</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:26.269Z</lastUpdated>
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    <udiDi>06974269382044</udiDi>
    <basicUdiDi>B-06974269382044</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName>Oxygen mask</deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:22.699Z</lastUpdated>
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    <udiDi>06974269381689</udiDi>
    <basicUdiDi>B-06974269381689</basicUdiDi>
    <tradeName>BM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021983</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM0401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:41:06.822Z</lastUpdated>
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    <udiDi>06973351317346</udiDi>
    <basicUdiDi>B-06973351317346</basicUdiDi>
    <tradeName>Simple Oxygen Mask</tradeName>
    <deviceName>oxygen mask</deviceName>
    <manufacturerName>Ningbo Trustlab Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008493</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT012-110 Pediatric M</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:08:19.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973351317339</udiDi>
    <basicUdiDi>B-06973351317339</basicUdiDi>
    <tradeName>Simple Oxygen Mask</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>Ningbo Trustlab Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008493</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT012-110</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:08:18.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932765887</udiDi>
    <basicUdiDi>69449327FR01A01JV</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A01011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.327Z</lastUpdated>
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    <udiDi>06944932765924</udiDi>
    <basicUdiDi>69449327FR01A01JV</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A01021F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.305Z</lastUpdated>
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    <udiDi>06944932765962</udiDi>
    <basicUdiDi>69449327FR01A01JV</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A01031F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.282Z</lastUpdated>
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    <udiDi>06944932766006</udiDi>
    <basicUdiDi>69449327FR01A01JV</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A01041F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.258Z</lastUpdated>
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    <udiDi>06944932766082</udiDi>
    <basicUdiDi>69449327FR01A00JT</basicUdiDi>
    <tradeName>Welllead Oxygen Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A02011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.230Z</lastUpdated>
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    <udiDi>06944932766105</udiDi>
    <basicUdiDi>69449327FR01A00JT</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A02021F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.208Z</lastUpdated>
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    <udiDi>06944932766129</udiDi>
    <basicUdiDi>69449327FR01A00JT</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A02031F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.184Z</lastUpdated>
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