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    <tradeName>Hemodialysis Equipment</tradeName>
    <deviceName>Hemodialysis Equipment</deviceName>
    <manufacturerName>GUANGZHOU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000036303</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>HAEMODIALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S01020200001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:43:38.282Z</lastUpdated>
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    <deviceName>Medical Angiography X-ray System</deviceName>
    <manufacturerName>Lepu Medical Equipment (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017314</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vicor-CV SWIFT</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:26:31.689Z</lastUpdated>
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    <deviceName>DISPOSABLE TIPS</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:57.697Z</lastUpdated>
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    <deviceName>DISPOSABLE TIPS</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:55.297Z</lastUpdated>
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    <udiDi>06973609155041</udiDi>
    <basicUdiDi>697360915504L7</basicUdiDi>
    <tradeName>06973609155041</tradeName>
    <deviceName>DISPOSABLE TIPS</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:53.697Z</lastUpdated>
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    <tradeName>06973609155034</tradeName>
    <deviceName>DISPOSABLE TIPS</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:52.915Z</lastUpdated>
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    <deviceName>DISPOSABLE TIPS</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:51.298Z</lastUpdated>
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    <deviceName>Fully Automated ELISA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0201020101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:48.898Z</lastUpdated>
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    <deviceName>DISPOSABLE TIPS</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:47.298Z</lastUpdated>
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    <deviceName>DISPOSABLE TIPS</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:46.512Z</lastUpdated>
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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609151135（11）210110（21）5B62021001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:44.897Z</lastUpdated>
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    <udiDi>06973609151128</udiDi>
    <basicUdiDi>697360915112KJ</basicUdiDi>
    <tradeName>06973609151128</tradeName>
    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609151128（11）200815（21）5B22020189</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:29.640Z</lastUpdated>
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    <basicUdiDi>697360915111KG</basicUdiDi>
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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609151111（11）210106（21）5B12021001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:28.858Z</lastUpdated>
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    <udiDi>06973609151050</udiDi>
    <basicUdiDi>697360915105KM</basicUdiDi>
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    <deviceName>Fully Automated Biochemistry Analyzer</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010102</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609151050（11）210113（21）5A52021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:28.038Z</lastUpdated>
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    <basicUdiDi>697360915080KW</basicUdiDi>
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    <deviceName>Fully Automated CLIA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020103</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput &gt; 250 and &lt;= 700 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150800（11）210110（21）5802021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:24.045Z</lastUpdated>
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    <deviceName>Fully Automated Blood Grouping System</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030102</emdnCode>
    <emdnDescription>AUTOMATED BLOOD GROUPING ANALYSERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150770（11）210112（21）5772021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:23.235Z</lastUpdated>
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    <deviceName>Fully Automated Blood Grouping System</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030102</emdnCode>
    <emdnDescription>AUTOMATED BLOOD GROUPING ANALYSERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150763（11）210113（21）5762021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:22.432Z</lastUpdated>
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    <deviceName>Fully Automated Blood Grouping System</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202030102</emdnCode>
    <emdnDescription>AUTOMATED BLOOD GROUPING ANALYSERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150756（11）210110（21）5752021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:21.633Z</lastUpdated>
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    <basicUdiDi>697360915056KZ</basicUdiDi>
    <tradeName>06973609150565</tradeName>
    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150565（11）210103（21）5562021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:17.630Z</lastUpdated>
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    <basicUdiDi>697360915034KP</basicUdiDi>
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    <deviceName>Automated Liquid Handling System</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609150343（11）210110（21）5382021001</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:16.843Z</lastUpdated>
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