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    <deviceName>Pepsinogen Ⅰ (PGⅠ) detection kit (magnetic particle CLIA)</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.02.140C1.020</reference>
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    <lastUpdated>2026-07-06T14:47:09.482Z</lastUpdated>
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    <tradeName>06973914381654</tradeName>
    <deviceName>PepsinogenⅡ(PGⅡ) detection kit (magnetic particle CLIA)</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
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    <tradeName>Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality Control：1mL×2(92014)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:38:40.900Z</lastUpdated>
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    <basicUdiDi>B-06971674867913</basicUdiDi>
    <tradeName>Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen I (PG I) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator：1mL×6(91021)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:37:24.643Z</lastUpdated>
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    <basicUdiDi>B-06971674867050</basicUdiDi>
    <tradeName>Pepsinogen II (PG II) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen II (PG II) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4(707)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:23.476Z</lastUpdated>
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    <basicUdiDi>B-06971674867043</basicUdiDi>
    <tradeName>Pepsinogen II (PG II) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen II (PG II) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×1  R2:5mL×1(702)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:22.575Z</lastUpdated>
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    <basicUdiDi>B-06971674867036</basicUdiDi>
    <tradeName>Pepsinogen II (PG II) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen II (PG II) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4(709)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:20.967Z</lastUpdated>
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    <tradeName>Pepsinogen II (PG II) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen II (PG II) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:12mL×2(701)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:18.571Z</lastUpdated>
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    <udiDi>06971674867005</udiDi>
    <basicUdiDi>B-06971674867005</basicUdiDi>
    <tradeName>Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen I (PG I) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×1  R2:5mL×1(702)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:17.067Z</lastUpdated>
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    <udiDi>06971674866992</udiDi>
    <basicUdiDi>B-06971674866992</basicUdiDi>
    <tradeName>Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen I (PG I) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4(709)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:16.458Z</lastUpdated>
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    <udiDi>06971674867012</udiDi>
    <basicUdiDi>B-06971674867012</basicUdiDi>
    <tradeName>Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen I (PG I) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4(707)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:14.572Z</lastUpdated>
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    <udiDi>06971674866985</udiDi>
    <basicUdiDi>B-06971674866985</basicUdiDi>
    <tradeName>Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Pepsinogen I (PG I) Test Kit (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>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:12mL×2(701)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:33:12.177Z</lastUpdated>
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    <udiDi>D-000012807181062PY</udiDi>
    <basicUdiDi>B-000012807181062PY</basicUdiDi>
    <tradeName>PGI/PGII Combined Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>PGI/PGII Combined Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT116</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:30.857Z</lastUpdated>
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    <udiDi>06936595750744</udiDi>
    <basicUdiDi>B-06936595750744</basicUdiDi>
    <tradeName>Pepsinogen Ⅱ Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ451Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:55:11.424Z</lastUpdated>
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    <basicUdiDi>B-06936595750737</basicUdiDi>
    <tradeName>Pepsinogen Ⅰ Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010127</emdnCode>
    <emdnDescription>PEPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ450Y</reference>
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    <lastUpdated>2026-06-24T15:55:10.222Z</lastUpdated>
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