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    <deviceName>Urea-[13C]Breath Test Kit</deviceName>
    <manufacturerName>JiangSu ETest Medical Electronic Technology Co Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050551</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETest4100-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:39:29.400Z</lastUpdated>
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    <basicUdiDi>B-06978198483100</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <basicUdiDi>B-06978198483094</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:24.577Z</lastUpdated>
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    <udiDi>06978198483070</udiDi>
    <basicUdiDi>B-06978198483070</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:23.858Z</lastUpdated>
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    <udiDi>06978198483063</udiDi>
    <basicUdiDi>B-06978198483063</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:19.862Z</lastUpdated>
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    <basicUdiDi>B-06978198483056</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:19.316Z</lastUpdated>
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    <udiDi>06978198483049</udiDi>
    <basicUdiDi>B-06978198483049</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:18.277Z</lastUpdated>
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    <udiDi>06978198483032</udiDi>
    <basicUdiDi>B-06978198483032</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:17.384Z</lastUpdated>
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    <udiDi>06978198483025</udiDi>
    <basicUdiDi>B-06978198483025</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:13.373Z</lastUpdated>
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    <udiDi>06978198483018</udiDi>
    <basicUdiDi>B-06978198483018</basicUdiDi>
    <tradeName>Urinalysis Strip</tradeName>
    <deviceName>Urinalysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:12.576Z</lastUpdated>
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    <udiDi>06975808410198</udiDi>
    <basicUdiDi>B-06975808410198</basicUdiDi>
    <tradeName>06975808410198</tradeName>
    <deviceName>Creatinine, Microalbumin in Urine Assay kit (Dry Chemical Method)</deviceName>
    <manufacturerName>Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044320</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:11:56.590Z</lastUpdated>
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    <udiDi>06974735361351</udiDi>
    <basicUdiDi>B-06974735361351</basicUdiDi>
    <tradeName>KEYU Dry Chemistry Strip</tradeName>
    <deviceName>Dry Chemistry Strip</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-14</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:34:34.560Z</lastUpdated>
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    <udiDi>06974735361344</udiDi>
    <basicUdiDi>B-06974735361344</basicUdiDi>
    <tradeName>KEYU Dry Chemistry Strip</tradeName>
    <deviceName>Dry Chemistry Strip</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:34:32.945Z</lastUpdated>
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    <udiDi>06974735360330</udiDi>
    <basicUdiDi>B-06974735360330</basicUdiDi>
    <tradeName>KEYU Urine Reagent Strips</tradeName>
    <deviceName>Urine Reagent Strips</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-14A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:37.566Z</lastUpdated>
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    <basicUdiDi>B-06974735360323</basicUdiDi>
    <tradeName>KEYU Urine Reagent Strips</tradeName>
    <deviceName>Urine Reagent Strips</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-12B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:35.174Z</lastUpdated>
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    <udiDi>06974541565509</udiDi>
    <basicUdiDi>B-06974541565509</basicUdiDi>
    <tradeName>06974541565509</tradeName>
    <deviceName>Urinary Tract Infection (UTI) &amp;DR Panel (Fluorescence PCR method)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PR2024-UT01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:32.840Z</lastUpdated>
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    <basicUdiDi>B-06974410142077</basicUdiDi>
    <tradeName>06974410142077</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-14H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:50.815Z</lastUpdated>
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    <basicUdiDi>B-06974410142060</basicUdiDi>
    <tradeName>Urine Strip</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-11H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:50.147Z</lastUpdated>
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    <tradeName>06974410142091</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-14F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:48.403Z</lastUpdated>
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