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<eudamedExport entity="devices">
  <row>
    <udiDi>06930251802334</udiDi>
    <basicUdiDi>69302518BPWD02JX</basicUdiDi>
    <tradeName>06930251802334</tradeName>
    <deviceName>Wrist Blood Pressure Monitor</deviceName>
    <manufacturerName>Andon Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001799</manufacturerSrn>
    <authorisedRepresentativeName>iHealthLabs Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000340</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05020102</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, BOXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD-722  TRANSPORT BOX</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:48:27.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103012703</udiDi>
    <basicUdiDi>69281030127XEZ</basicUdiDi>
    <tradeName>06928103012703</tradeName>
    <deviceName>RNA/DNA Extraction or Purification Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1270</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:53.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103010006</udiDi>
    <basicUdiDi>69281030100XE2</basicUdiDi>
    <tradeName>06928103010006</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1000</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:51.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103009802</udiDi>
    <basicUdiDi>69281030098XFY</basicUdiDi>
    <tradeName>06928103009802</tradeName>
    <deviceName>Specimen Preservation Solution</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0980</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:50.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103009703</udiDi>
    <basicUdiDi>69281030097XFV</basicUdiDi>
    <tradeName>06928103009703</tradeName>
    <deviceName>Specimen Preservation Reagent</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0970</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:49.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103009604</udiDi>
    <basicUdiDi>69281030096XFS</basicUdiDi>
    <tradeName>06928103009604</tradeName>
    <deviceName>RNA/DNA Purification Kit (Preservation/Release)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0960</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:46.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103009505</udiDi>
    <basicUdiDi>69281030095XFP</basicUdiDi>
    <tradeName>06928103009505</tradeName>
    <deviceName>RNA/DNA Purification Kit (Release)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0950</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:45.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103009406</udiDi>
    <basicUdiDi>69281030094XFL</basicUdiDi>
    <tradeName>06928103009406</tradeName>
    <deviceName>RNA/DNA Purification Kit (Preservation)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0940</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:44.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103008706</udiDi>
    <basicUdiDi>69281030087XFQ</basicUdiDi>
    <tradeName>06928103008706</tradeName>
    <deviceName>Nucleic Acid Isolation or Purification Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0870</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:43.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103006603</udiDi>
    <basicUdiDi>69281030066XFB</basicUdiDi>
    <tradeName>06928103006603</tradeName>
    <deviceName>RNA/DNA Extraction or Purification Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0660</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:43.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103006504</udiDi>
    <basicUdiDi>69281030065XF8</basicUdiDi>
    <tradeName>06928103006504</tradeName>
    <deviceName>RNA/DNA Extraction or Purification Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0650</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:39.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103006405</udiDi>
    <basicUdiDi>69281030064XF5</basicUdiDi>
    <tradeName>06928103006405</tradeName>
    <deviceName>RNA/DNA Extraction or Purification Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0640</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:39.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103006306</udiDi>
    <basicUdiDi>69281030063XF2</basicUdiDi>
    <tradeName>06928103006306</tradeName>
    <deviceName>RNA/DNA Purification Kit (Magnetic Bead)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0630</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:39.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103006207</udiDi>
    <basicUdiDi>69281030062XEX</basicUdiDi>
    <tradeName>06928103006207</tradeName>
    <deviceName>Nucleic Acid Isolation or Purification Reagent</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:31.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103006009</udiDi>
    <basicUdiDi>69281030060XER</basicUdiDi>
    <tradeName>06928103006009</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:29.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103005903</udiDi>
    <basicUdiDi>69281030059XFF</basicUdiDi>
    <tradeName>06928103005903</tradeName>
    <deviceName>RNA/DNA Purification Kit (Spin Column)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0590</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:29.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912708513</udiDi>
    <basicUdiDi>692591270147HG</basicUdiDi>
    <tradeName>06925912708513</tradeName>
    <deviceName>Reaction vessel</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:39.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925200118017</udiDi>
    <basicUdiDi>69252001samplingtube68</basicUdiDi>
    <tradeName>06925200118017</tradeName>
    <deviceName>Disposable Virus Sampling Tube</deviceName>
    <manufacturerName>Nanchang Chaoyang Medical and Health Products Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041284</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>non inactivated -6.0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:26:08.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924432300016</udiDi>
    <basicUdiDi>69244323VBCT001N8</basicUdiDi>
    <tradeName>06924432300016</tradeName>
    <deviceName>VACUUM  BLOOD COLLECTION TUBE</deviceName>
    <manufacturerName>CANGZHOU YONGKANG MEDICAL DEVICES CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000035087</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010202</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:24:53.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921756496593</udiDi>
    <basicUdiDi>6921756499990022WX</basicUdiDi>
    <tradeName>Promotor Sample Collection Kit</tradeName>
    <deviceName>Sample Collection Kit</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P121-1471-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:10:58.754Z</lastUpdated>
  </row>
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