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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:45.080Z</lastUpdated>
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    <udiDi>06971674869436</udiDi>
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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×1  R2:20mL×1（708）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:43.218Z</lastUpdated>
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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:41.372Z</lastUpdated>
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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:30mL×1  R2:10mL×1（705）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:40.277Z</lastUpdated>
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    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:30mL×1  R2:10mL×1（704）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:38.885Z</lastUpdated>
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    <basicUdiDi>B-06971674869399</basicUdiDi>
    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</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>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:30mL×1  R2:10mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:37.606Z</lastUpdated>
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    <basicUdiDi>B-06971674869382</basicUdiDi>
    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:30mL×2  R2:20mL×1（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:34.380Z</lastUpdated>
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    <basicUdiDi>B-06971674869375</basicUdiDi>
    <tradeName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×1  R2:20mL×1（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:32.535Z</lastUpdated>
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    <basicUdiDi>B-06971674868354</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>质控品：1mL×2（92143）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:07.123Z</lastUpdated>
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    <basicUdiDi>B-06971674868286</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>质控品：0.5mL×2（92142）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:38:59.087Z</lastUpdated>
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    <tradeName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>校准品：1mL×5（91130）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:37:35.194Z</lastUpdated>
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    <basicUdiDi>B-06971674867876</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)Test Kit  (Enzymatic)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>校准品：0.5mL×2（91129）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:37:15.547Z</lastUpdated>
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    <basicUdiDi>B-06971225939052</basicUdiDi>
    <tradeName>Hemolysis</tradeName>
    <deviceName>Hemolysis</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHL2000</reference>
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    <tradeName>Hemolysis</tradeName>
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    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>HbA1c Elution Buffer C</tradeName>
    <deviceName>HbA1c Elution Buffer C</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH3800</reference>
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    <tradeName>HbA1c Elution Buffer C</tradeName>
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    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>HbA1c Elution Buffer B</tradeName>
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    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH2400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:30:14.105Z</lastUpdated>
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