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    <tradeName>06928103012727</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1272</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:01.096Z</lastUpdated>
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    <udiDi>06928103012734</udiDi>
    <basicUdiDi>69281030127XEZ</basicUdiDi>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1273</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:01.077Z</lastUpdated>
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    <udiDi>06928103012741</udiDi>
    <basicUdiDi>69281030127XEZ</basicUdiDi>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1274</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:01.055Z</lastUpdated>
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    <udiDi>06928103012758</udiDi>
    <basicUdiDi>69281030127XEZ</basicUdiDi>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1275</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:01.023Z</lastUpdated>
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    <udiDi>06928103013908</udiDi>
    <basicUdiDi>B-06928103013908</basicUdiDi>
    <tradeName>06928103013908</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1390</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:01.002Z</lastUpdated>
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    <udiDi>06928103013915</udiDi>
    <basicUdiDi>B-06928103013915</basicUdiDi>
    <tradeName>06928103013915</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1391</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.985Z</lastUpdated>
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    <udiDi>06928103014004</udiDi>
    <basicUdiDi>B-06928103014004</basicUdiDi>
    <tradeName>06928103014004</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.971Z</lastUpdated>
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    <udiDi>06928103014011</udiDi>
    <basicUdiDi>B-06928103014011</basicUdiDi>
    <tradeName>06928103014011</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1401</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.956Z</lastUpdated>
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    <udiDi>06928103014301</udiDi>
    <basicUdiDi>B-06928103014301</basicUdiDi>
    <tradeName>06928103014301</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1430</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.942Z</lastUpdated>
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    <udiDi>06928103014318</udiDi>
    <basicUdiDi>B-06928103014318</basicUdiDi>
    <tradeName>06928103014318</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1431</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.925Z</lastUpdated>
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    <udiDi>06928103014806</udiDi>
    <basicUdiDi>69281030094XFL</basicUdiDi>
    <tradeName>06928103014806</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1480</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.901Z</lastUpdated>
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    <udiDi>06928103014813</udiDi>
    <basicUdiDi>69281030094XFL</basicUdiDi>
    <tradeName>06928103014813</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA1481</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.870Z</lastUpdated>
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    <udiDi>06928103080443</udiDi>
    <basicUdiDi>69281030804XFX</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction Instrument</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.813Z</lastUpdated>
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  <row>
    <udiDi>06928103080450</udiDi>
    <basicUdiDi>69281030804XFX</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction Instrument</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.799Z</lastUpdated>
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