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<eudamedExport entity="devices">
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    <udiDi>04987481165137</udiDi>
    <basicUdiDi>49874814987481165120TX</basicUdiDi>
    <tradeName>NEFA-HR(2) R2 Set</tradeName>
    <deviceName>NEFA-HR(2) R1 Set, NEFA-HR(2) R2 Set, NEFA Standard</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990-91901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:19.656Z</lastUpdated>
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  <row>
    <udiDi>04987481165120</udiDi>
    <basicUdiDi>49874814987481165120TX</basicUdiDi>
    <tradeName>NEFA-HR(2) R1 Set</tradeName>
    <deviceName>NEFA-HR(2) R1 Set, NEFA-HR(2) R2 Set, NEFA Standard</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>994-91801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:50.713Z</lastUpdated>
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  <row>
    <udiDi>D-6-129FQ</udiDi>
    <basicUdiDi>B-6-129FQ</basicUdiDi>
    <tradeName>D-6-129FQ</tradeName>
    <deviceName>Nonesterified Fatty Acid (NEFA) Assay Kit (ACS-ACOD Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000732, USCA00000735 USCA00000733 USCA00000734, USCA00000736"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:31.006Z</lastUpdated>
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  <row>
    <udiDi>D-1887H</udiDi>
    <basicUdiDi>B-1887H</basicUdiDi>
    <tradeName>D-1887H</tradeName>
    <deviceName>Free Fatty Acid Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T08:08:16.123Z</lastUpdated>
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  <row>
    <udiDi>08435287111781</udiDi>
    <basicUdiDi>B-08435287111781</basicUdiDi>
    <tradeName>08435287111781</tradeName>
    <deviceName>NON-ESTERIFIED FATTY ACIDS (NEFA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21840</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:46:06.980Z</lastUpdated>
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  <row>
    <udiDi>08435287111774</udiDi>
    <basicUdiDi>B-08435287111774</basicUdiDi>
    <tradeName>08435287111774</tradeName>
    <deviceName>NON-ESTERIFIED FATTY ACIDS (NEFA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12540</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:46:06.174Z</lastUpdated>
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  <row>
    <udiDi>08435287111767</udiDi>
    <basicUdiDi>B-08435287111767</basicUdiDi>
    <tradeName>08435287111767</tradeName>
    <deviceName>NON-ESTERIFIED FATTY ACIDS (NEFA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11840</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:46:02.174Z</lastUpdated>
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  <row>
    <udiDi>06974760129834</udiDi>
    <basicUdiDi>B-06974760129834</basicUdiDi>
    <tradeName>06974760129834</tradeName>
    <deviceName>Nonesterified Fatty Acid （NEFA）Assay Kit（ACS-ACOD Method）</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:00.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674860761</udiDi>
    <basicUdiDi>B-06971674860761</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2(716)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:08.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674860754</udiDi>
    <basicUdiDi>B-06971674860754</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2(715)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:08.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674860747</udiDi>
    <basicUdiDi>B-06971674860747</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2(713)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:06.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674860730</udiDi>
    <basicUdiDi>B-06971674860730</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4(710)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:06.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674860723</udiDi>
    <basicUdiDi>B-06971674860723</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2(798)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:01.561Z</lastUpdated>
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  <row>
    <udiDi>06971674860716</udiDi>
    <basicUdiDi>B-06971674860716</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4(796)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:00.013Z</lastUpdated>
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  <row>
    <udiDi>06971674860709</udiDi>
    <basicUdiDi>B-06971674860709</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×6  R2:60mL×2(795)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:08:59.217Z</lastUpdated>
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  <row>
    <udiDi>06971674860693</udiDi>
    <basicUdiDi>B-06971674860693</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:32mL×1(793)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:08:58.605Z</lastUpdated>
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  <row>
    <udiDi>06971674860686</udiDi>
    <basicUdiDi>B-06971674860686</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:32mL×1(792)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:08:55.128Z</lastUpdated>
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  <row>
    <udiDi>06971674860679</udiDi>
    <basicUdiDi>B-06971674860679</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2(791)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:08:54.023Z</lastUpdated>
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  <row>
    <udiDi>06971674860662</udiDi>
    <basicUdiDi>B-06971674860662</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:90mL×1  R2:30mL×1(708)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:08:53.578Z</lastUpdated>
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  <row>
    <udiDi>06971674860655</udiDi>
    <basicUdiDi>B-06971674860655</basicUdiDi>
    <tradeName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</tradeName>
    <deviceName>Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010222</emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4(707)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:08:53.470Z</lastUpdated>
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