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    <tradeName>Urine Sediment Analyzer Reagent Diluent</tradeName>
    <deviceName>Urinalysis Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3007269</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:58.364Z</lastUpdated>
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    <udiDi>++G322001256D</udiDi>
    <basicUdiDi>++G322G322001256D16KZ</basicUdiDi>
    <tradeName>ENNOLIFE ACR &amp; UPCR Test for Urinalysis (Non-sterile)</tradeName>
    <deviceName>ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)</deviceName>
    <manufacturerName>ProtectLife International Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000039217</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-256D</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:30:34.567Z</lastUpdated>
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    <udiDi>++G322001237A</udiDi>
    <basicUdiDi>++G322G322001237A12JT</basicUdiDi>
    <tradeName>ENNOLIFE Kidney Panel II</tradeName>
    <deviceName>ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)</deviceName>
    <manufacturerName>ProtectLife International Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000039217</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-237A</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:30:28.970Z</lastUpdated>
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    <udiDi>06977367850019</udiDi>
    <basicUdiDi>B-06977367850019</basicUdiDi>
    <tradeName>06977367850019</tradeName>
    <deviceName>Glycated hemoglobin test kit (High-performance liquid chromatography)</deviceName>
    <manufacturerName>Changchun Chenyu Taikang Medical Laboratory Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000046653</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020301</emdnCode>
    <emdnDescription>URINE SEDIMENTTEST KIT (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:17:31.213Z</lastUpdated>
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    <udiDi>06972838800050</udiDi>
    <basicUdiDi>B-06972838800050</basicUdiDi>
    <tradeName>06972838800050</tradeName>
    <deviceName>M2-PK/MMP9/MPO/GST-Pi/RBP4/Calprotectin/FIT Multi-Target Test Kits (Colloidal Gold Immunochromatography Method)</deviceName>
    <manufacturerName>FAMID Biomedical Technology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051665</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100T/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:07:12.619Z</lastUpdated>
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    <udiDi>06972838800043</udiDi>
    <basicUdiDi>B-06972838800043</basicUdiDi>
    <tradeName>06972838800043</tradeName>
    <deviceName>M2-PK/MMP9/MPO/GST-Pi/RBP4/Calprotectin/FIT Multi-Target Test Kits (Colloidal Gold Immunochromatography Method)</deviceName>
    <manufacturerName>FAMID Biomedical Technology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051665</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:07:07.820Z</lastUpdated>
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    <udiDi>06972838800036</udiDi>
    <basicUdiDi>B-06972838800036</basicUdiDi>
    <tradeName>06972838800036</tradeName>
    <deviceName>M2-PK/MMP9/MPO/GST-Pi/RBP4/Calprotectin/FIT Multi-Target Test Kits (Colloidal Gold Immunochromatography Method)</deviceName>
    <manufacturerName>FAMID Biomedical Technology (Tianjin) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051665</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1T/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:07:07.022Z</lastUpdated>
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    <udiDi>06972412612024</udiDi>
    <basicUdiDi>B-06972412612024</basicUdiDi>
    <tradeName>06972412612024</tradeName>
    <deviceName>Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Code:303034</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020301</emdnCode>
    <emdnDescription>URINE SEDIMENTTEST KIT (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303034</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:50:23.928Z</lastUpdated>
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    <udiDi>06972412612017</udiDi>
    <basicUdiDi>B-06972412612017</basicUdiDi>
    <tradeName>06972412612017</tradeName>
    <deviceName>Novel Coronavirus(COVID-19) Antigen Test Kit(Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020301</emdnCode>
    <emdnDescription>URINE SEDIMENTTEST KIT (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:50:23.136Z</lastUpdated>
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  <row>
    <udiDi>06925794576484</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Urine Sediment Analyzer Reagent Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001173</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:15:03.707Z</lastUpdated>
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  <row>
    <udiDi>06925794577276</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Urine Sediment Analyzer Reagent Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019953</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.833Z</lastUpdated>
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    <udiDi>06925794577306</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Urine Sediment Analyzer Reagent Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019967</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.787Z</lastUpdated>
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    <udiDi>06925794577313</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019895</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.776Z</lastUpdated>
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    <udiDi>06925794577320</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Urine Sediment Analyzer Reagent Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019954</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.764Z</lastUpdated>
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    <udiDi>06925794577344</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>FUS Series Urinalysis Hybrid Sheath II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019943</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.729Z</lastUpdated>
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    <udiDi>06925794577368</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>FUS Series Urinalysis Hybrid Sheath II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019934</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.684Z</lastUpdated>
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    <udiDi>06925794577382</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Urine Sediment Analyzer Reagent Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019946</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.646Z</lastUpdated>
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    <udiDi>06925794577399</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019968</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.627Z</lastUpdated>
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    <udiDi>06925794587473</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3020856</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:42.005Z</lastUpdated>
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    <udiDi>06925794587480</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3020855</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:41.987Z</lastUpdated>
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