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    <tradeName>BCIP/NBT Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <udiDi>06976457970972</udiDi>
    <basicUdiDi>B-06976457970972</basicUdiDi>
    <tradeName>EUYI p16/Ki-67 Dual Staining kit (immunocytochemical method)</tradeName>
    <deviceName>EUYI p16/Ki-67 Dual Staining kit (immunocytochemical method)</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <basicUdiDi>B-06976457970965</basicUdiDi>
    <tradeName>EUYI p16/Ki-67 Dual Staining kit (immunocytochemical method)</tradeName>
    <deviceName>EUYI p16/Ki-67 Dual Staining kit (immunocytochemical method)</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <udiDi>06975503529225</udiDi>
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    <tradeName>CA 19-9 Antibody Reagent (Immunohistochemistry)</tradeName>
    <deviceName>CA 19-9 Antibody Reagent (Immunohistochemistry)</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRDB139</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:30:14.907Z</lastUpdated>
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    <udiDi>06975503520444</udiDi>
    <basicUdiDi>B-06975503520444</basicUdiDi>
    <tradeName>Immunochromogenic Reagent</tradeName>
    <deviceName>Immunochromogenic Reagent</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD4044</reference>
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    <lastUpdated>2026-07-06T19:54:58.144Z</lastUpdated>
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    <udiDi>06975296640534</udiDi>
    <basicUdiDi>B-06975296640534</basicUdiDi>
    <tradeName>06975296640534</tradeName>
    <deviceName>PD-L1(E1L3N) Antibody Kit(IHC)</deviceName>
    <manufacturerName>MEDx (Suzhou) Translational Medicine Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU008A01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:26:47.957Z</lastUpdated>
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    <basicUdiDi>B-06975296640510</basicUdiDi>
    <tradeName>06975296640510</tradeName>
    <deviceName>Claudin 18.2 Antibody Kit(IHC)</deviceName>
    <manufacturerName>MEDx (Suzhou) Translational Medicine Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028603</manufacturerSrn>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:26:43.160Z</lastUpdated>
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    <basicUdiDi>B-06927210914214</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01030711</emdnCode>
    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0586</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:53.754Z</lastUpdated>
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    <basicUdiDi>B-06927210914207</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0586</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:53.202Z</lastUpdated>
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    <udiDi>06927210914191</udiDi>
    <basicUdiDi>B-06927210914191</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0586</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:52.158Z</lastUpdated>
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    <udiDi>06927210914184</udiDi>
    <basicUdiDi>B-06927210914184</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0586</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:47.344Z</lastUpdated>
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    <udiDi>06927210914177</udiDi>
    <basicUdiDi>B-06927210914177</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01030711</emdnCode>
    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0582</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:46.548Z</lastUpdated>
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    <udiDi>06927210914160</udiDi>
    <basicUdiDi>B-06927210914160</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030711</emdnCode>
    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0582</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:45.740Z</lastUpdated>
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    <udiDi>06927210914153</udiDi>
    <basicUdiDi>B-06927210914153</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0582</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:44.943Z</lastUpdated>
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    <udiDi>06927210914146</udiDi>
    <basicUdiDi>B-06927210914146</basicUdiDi>
    <tradeName>ISH Detection Kit</tradeName>
    <deviceName>ISH Detection Kit</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0582</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:40.944Z</lastUpdated>
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    <udiDi>06927210913903</udiDi>
    <basicUdiDi>B-06927210913903</basicUdiDi>
    <tradeName>Alkaline Phosphatase Red Detection Kit</tradeName>
    <deviceName>Immunochromogenic Reagent</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0558</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:14:27.847Z</lastUpdated>
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    <udiDi>06927210913873</udiDi>
    <basicUdiDi>B-06927210913873</basicUdiDi>
    <tradeName>Alkaline Phosphatase Red Detection Kit</tradeName>
    <deviceName>Immunochromogenic Reagent</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0558</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:14:25.749Z</lastUpdated>
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    <basicUdiDi>B-06927210913859</basicUdiDi>
    <tradeName>Alkaline Phosphatase Red Detection Kit</tradeName>
    <deviceName>Immunochromogenic Reagent</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
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    <reference>DMRD0558</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:14:22.920Z</lastUpdated>
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    <basicUdiDi>B-06927210913750</basicUdiDi>
    <tradeName>Immunochromogenic Reagent Ⅱ</tradeName>
    <deviceName>Immunochromogenic Reagent</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0369</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:14:07.588Z</lastUpdated>
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    <udiDi>06927210913743</udiDi>
    <basicUdiDi>B-06927210913743</basicUdiDi>
    <tradeName>Immunochromogenic Reagent Ⅱ</tradeName>
    <deviceName>Immunochromogenic Reagent</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W01030711</emdnCode>
    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0369</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:14:05.995Z</lastUpdated>
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