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    <tradeName>06935740714204</tradeName>
    <deviceName>Urine Reagent Strips</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:27.285Z</lastUpdated>
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    <udiDi>06935740714143</udiDi>
    <basicUdiDi>69357407IUCS000010QM</basicUdiDi>
    <tradeName>06935740714143</tradeName>
    <deviceName>Urine Reagent Strips</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:26.481Z</lastUpdated>
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    <udiDi>06935740714129</udiDi>
    <basicUdiDi>69357407IUCS000009R4</basicUdiDi>
    <tradeName>06935740714129</tradeName>
    <deviceName>Urine Reagent Strips</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:25.696Z</lastUpdated>
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    <udiDi>06935740714099</udiDi>
    <basicUdiDi>69357407IUCS000012QR</basicUdiDi>
    <tradeName>06935740714099</tradeName>
    <deviceName>Urine Reagent Strips</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:24.890Z</lastUpdated>
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    <udiDi>06935740713924</udiDi>
    <basicUdiDi>69357407IUSS00000229</basicUdiDi>
    <tradeName>URIT FC 23 Focusing Fluid for Urine Sediment Analyzer</tradeName>
    <deviceName>Focusing Fluid for Urine Sediment Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:24.191Z</lastUpdated>
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    <udiDi>06935740713870</udiDi>
    <basicUdiDi>69357407IUSS0000112A</basicUdiDi>
    <tradeName>URIT QC 22 Control Material for Urine Sediment Analyzer</tradeName>
    <deviceName>Control Material for Urine Sediment Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:22.495Z</lastUpdated>
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    <udiDi>04046681163562</udiDi>
    <basicUdiDi>4046681151064W7</basicUdiDi>
    <tradeName>Uralyt-U® pH 5.6-8.0</tradeName>
    <deviceName>Uralyt-U® pH 5.6-8.0</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90125.8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:17:02.387Z</lastUpdated>
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    <udiDi>04046681142802</udiDi>
    <basicUdiDi>4046681151057WA</basicUdiDi>
    <tradeName>Medi-Test Glucose BHR</tradeName>
    <deviceName>Medi-Test Glucose</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>93001.203880</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:17:00.769Z</lastUpdated>
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    <udiDi>04046681141683</udiDi>
    <basicUdiDi>4046681151897XW</basicUdiDi>
    <tradeName>URYXXON® Control Strip</tradeName>
    <deviceName>URYXXON® Control Strip</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930988</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:16:55.176Z</lastUpdated>
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    <udiDi>04046681000607</udiDi>
    <basicUdiDi>4046681151033VU</basicUdiDi>
    <tradeName>Medi-Test Control</tradeName>
    <deviceName>Medi-Test Control</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:16:36.690Z</lastUpdated>
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  <row>
    <udiDi>04046681000003</udiDi>
    <basicUdiDi>4046681151040VR</basicUdiDi>
    <tradeName>Medi-Test Glucose</tradeName>
    <deviceName>Medi-Test URYXXON® Stick 10</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:16:35.103Z</lastUpdated>
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  <row>
    <udiDi>06971007252218</udiDi>
    <basicUdiDi>B-06971007252218</basicUdiDi>
    <tradeName>06971007252218</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-11H (3 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:22:10.286Z</lastUpdated>
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  <row>
    <udiDi>06971007252201</udiDi>
    <basicUdiDi>B-06971007252201</basicUdiDi>
    <tradeName>06971007252201</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-13H (3 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:22:09.091Z</lastUpdated>
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  <row>
    <udiDi>06971007252195</udiDi>
    <basicUdiDi>B-06971007252195</basicUdiDi>
    <tradeName>06971007252195</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-14H (3 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:22:07.880Z</lastUpdated>
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    <udiDi>06971007252034</udiDi>
    <basicUdiDi>B-06971007252034</basicUdiDi>
    <tradeName>06971007252034</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-9 (2 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:22:06.716Z</lastUpdated>
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    <udiDi>06971007252027</udiDi>
    <basicUdiDi>B-06971007252027</basicUdiDi>
    <tradeName>06971007252027</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-8 (2 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:22:00.676Z</lastUpdated>
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    <udiDi>06971007252010</udiDi>
    <basicUdiDi>B-06971007252010</basicUdiDi>
    <tradeName>06971007252010</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-7 (2 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:21:59.476Z</lastUpdated>
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    <udiDi>06971007252003</udiDi>
    <basicUdiDi>B-06971007252003</basicUdiDi>
    <tradeName>06971007252003</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-6 (2 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:21:58.294Z</lastUpdated>
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    <udiDi>06971007251990</udiDi>
    <basicUdiDi>B-06971007251990</basicUdiDi>
    <tradeName>06971007251990</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-5 (2 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:21:57.081Z</lastUpdated>
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    <udiDi>06971007251983</udiDi>
    <basicUdiDi>B-06971007251983</basicUdiDi>
    <tradeName>06971007251983</tradeName>
    <deviceName>Reagent strips for urinalysis</deviceName>
    <manufacturerName>Yercon Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028380</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-4 (2 strips/bag)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:21:51.080Z</lastUpdated>
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