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    <tradeName>XTF CLEARING AGENT - 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CellPath Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000022744</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEA-2000-00C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:06:03.058Z</lastUpdated>
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    <udiDi>05056256111156</udiDi>
    <basicUdiDi>05056256SEA00259</basicUdiDi>
    <tradeName>XTF CLEARING AGENT - 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CellPath Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000022744</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEA-2000-00D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:06:03.022Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>06928103006504</udiDi>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <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>
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    <udiDi>05999860094418</udiDi>
    <basicUdiDi>5999883586CLEVK</basicUdiDi>
    <tradeName>Solution 1</tradeName>
    <deviceName>Cleaning Solution</deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA000SL1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:44:45.299Z</lastUpdated>
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    <tradeName>5x TBS Wash Buffer</tradeName>
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    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWB56</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:40:47.990Z</lastUpdated>
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    <tradeName>LUMEA BxChip</tradeName>
    <deviceName>Sectionable Matrix for Biopsies S</deviceName>
    <manufacturerName>Themis Pathology</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BxC 001s.b</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:18:23.664Z</lastUpdated>
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    <tradeName>LUMEA BxChip</tradeName>
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    <manufacturerName>Themis Pathology</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T13:18:22.880Z</lastUpdated>
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    <tradeName>BGI</tradeName>
    <deviceName>Sample Releasing Agent</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0100060960</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:26.208Z</lastUpdated>
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