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    <basicUdiDi>803300326101000006KB</basicUdiDi>
    <tradeName>08033003260449</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS/50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:10:37.426Z</lastUpdated>
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    <udiDi>16975519160914</udiDi>
    <basicUdiDi>697551916OMNSTQ</basicUdiDi>
    <tradeName>16975519160914</tradeName>
    <deviceName>Disposable Oxygen Mask</deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Adult-S-02(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:46:18.491Z</lastUpdated>
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    <udiDi>16975519160587</udiDi>
    <basicUdiDi>697551916NOCNSSX</basicUdiDi>
    <tradeName>16975519160587</tradeName>
    <deviceName>Disposable Nasal Oxygen Cannula</deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Infant-14(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:46:17.702Z</lastUpdated>
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    <udiDi>06975519160023</udiDi>
    <basicUdiDi>697551916NOCV8</basicUdiDi>
    <tradeName>Disposable Nasal Oxygen Cannula</tradeName>
    <deviceName>Disposable Nasal Oxygen Cannula</deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NOC-Neonate-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:44:50.164Z</lastUpdated>
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    <udiDi>06972091922674</udiDi>
    <basicUdiDi>697209192TTM05PB</basicUdiDi>
    <tradeName>BM Tracheostomy Masks</tradeName>
    <deviceName>Tracheostomy Masks</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010205</emdnCode>
    <emdnDescription>TRACHEOSTOMY O2 SUPPLIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112 01 00 1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:31:09.533Z</lastUpdated>
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    <udiDi>06958949926049</udiDi>
    <basicUdiDi>6958949950JM</basicUdiDi>
    <tradeName>06958949926049</tradeName>
    <deviceName>Nasal cannula</deviceName>
    <manufacturerName>Hunan Beyond Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002143</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC1-S</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:53:38.315Z</lastUpdated>
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    <udiDi>06945099394309</udiDi>
    <basicUdiDi>69450993NOCSOS01KM</basicUdiDi>
    <tradeName>Soundway</tradeName>
    <deviceName>Nasal Cannula</deviceName>
    <manufacturerName>Ningbo Shengyurui Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026643</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1743</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:09.062Z</lastUpdated>
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    <udiDi>06945099393371</udiDi>
    <basicUdiDi>69450993NOCFLD01C6</basicUdiDi>
    <tradeName>Soundway</tradeName>
    <deviceName>Nasal Cannula</deviceName>
    <manufacturerName>Ningbo Shengyurui Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026643</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:08.275Z</lastUpdated>
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    <udiDi>06945099393173</udiDi>
    <basicUdiDi>69450993NOCSTD01JD</basicUdiDi>
    <tradeName>Soundway</tradeName>
    <deviceName>Nasal Cannula</deviceName>
    <manufacturerName>Ningbo Shengyurui Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026643</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:04.285Z</lastUpdated>
  </row>
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    <udiDi>06945099392718</udiDi>
    <basicUdiDi>69450993SOM001VF</basicUdiDi>
    <tradeName>Medium Concentration Oxygen Mask</tradeName>
    <deviceName>Medium Concentration Oxygen Mask</deviceName>
    <manufacturerName>Ningbo Shengyurui Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026643</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>A0101-S5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:02.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945099392190</udiDi>
    <basicUdiDi>69450993OMB001QQ</basicUdiDi>
    <tradeName>High Concentration Oxygen Mask</tradeName>
    <deviceName>High concentration oxygen mask</deviceName>
    <manufacturerName>Ningbo Shengyurui Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026643</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010206</emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0301-S5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:01.865Z</lastUpdated>
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    <udiDi>06945099370013</udiDi>
    <basicUdiDi>69450993NOC001R8</basicUdiDi>
    <tradeName>Nasal Cannula, SoftPlus, Paediatric, Standard lariat, 5mm-7ft, Standard connector</tradeName>
    <deviceName>nasal cannula</deviceName>
    <manufacturerName>Ningbo Shengyurui Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026643</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0206-S5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:07:55.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932770973</udiDi>
    <basicUdiDi>69449327FR01C01K7</basicUdiDi>
    <tradeName>Welllead Oxygen Tubing</tradeName>
    <deviceName>Oxygen Tubing</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>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01C01211X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:29.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932770966</udiDi>
    <basicUdiDi>69449327FR01C00K5</basicUdiDi>
    <tradeName>Welllead Oxygen Tubing</tradeName>
    <deviceName>Oxygen Tubing</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>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01C01211F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:27.152Z</lastUpdated>
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    <udiDi>06944932769878</udiDi>
    <basicUdiDi>69449327FR01B00JY</basicUdiDi>
    <tradeName>Oxygen Catheter</tradeName>
    <deviceName>Oxygen Catheter</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>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01B03081Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:25.541Z</lastUpdated>
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    <udiDi>06944932767577</udiDi>
    <basicUdiDi>69449327FR01A15K8</basicUdiDi>
    <tradeName>Welllead Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A07011Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:24.742Z</lastUpdated>
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    <udiDi>06944932767560</udiDi>
    <basicUdiDi>69449327FR01A16KA</basicUdiDi>
    <tradeName>Welllead  Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A07011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:23.587Z</lastUpdated>
  </row>
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    <udiDi>06944932766884</udiDi>
    <basicUdiDi>69449327FR01A06K7</basicUdiDi>
    <tradeName>Welllead  Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A05011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:23.466Z</lastUpdated>
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    <udiDi>06944932757400</udiDi>
    <basicUdiDi>69449327FR01A05K5</basicUdiDi>
    <tradeName>Welllead Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A05011Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:12.806Z</lastUpdated>
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    <udiDi>06944932751767</udiDi>
    <basicUdiDi>69449327FR01B09KJ</basicUdiDi>
    <tradeName>Welllead ETCO2 Sampling Cannula</tradeName>
    <deviceName>ETCO2 Sampling Cannula</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>MDR 2017/745</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01B02023F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:12.012Z</lastUpdated>
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