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    <tradeName>06977805760245</tradeName>
    <deviceName>Mycobacterium Multiplex-PCR Library Pre Kit</deviceName>
    <manufacturerName>Shenzhen Health SwifTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044339</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA05-01-24S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:52:06.508Z</lastUpdated>
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    <udiDi>06977805760214</udiDi>
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    <tradeName>06977805760214</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Health SwifTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044339</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>AA05-01-24S</reference>
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    <lastUpdated>2026-07-31T18:52:05.757Z</lastUpdated>
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    <udiDi>06944904032269</udiDi>
    <basicUdiDi>69449040004JG6PD*******C3</basicUdiDi>
    <tradeName>Glucose-6-Phosphate Dehydrogenase (G6PD) Kit (UV Enzymatic Method)</tradeName>
    <deviceName>Glucose-6-Phosphate Dehydrogenase Kit  (UV Enzymatic Method)、G6PD Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002254-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:53:34.757Z</lastUpdated>
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    <udiDi>06944904034959</udiDi>
    <basicUdiDi>694490400043AFU********F3</basicUdiDi>
    <tradeName>α-L-Fucosidase Kit (CNPF Method)</tradeName>
    <deviceName>α-L-Fucosidase Kit (CNPF Method)、AFU Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-003123-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:07.635Z</lastUpdated>
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    <udiDi>06903053011563</udiDi>
    <basicUdiDi>694490400043ADA********WS</basicUdiDi>
    <tradeName>Adenosine Deaminase Kit (Enzymatic Colorimetric Method)</tradeName>
    <deviceName>Adenosine Deaminase</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-026284-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:39.719Z</lastUpdated>
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    <udiDi>04050598164109</udiDi>
    <basicUdiDi>B-04050598164109</basicUdiDi>
    <tradeName>Pankreatische Amylase ELISA</tradeName>
    <deviceName>Pankreatische Amylase ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.374Z</lastUpdated>
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    <udiDi>04050598168404</udiDi>
    <basicUdiDi>B-04050598168404</basicUdiDi>
    <tradeName>IDK® PMN-Elastase ELISA</tradeName>
    <deviceName>IDK® PMN-Elastase ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.080Z</lastUpdated>
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    <udiDi>04050598182202</udiDi>
    <basicUdiDi>B-04050598182202</basicUdiDi>
    <tradeName>Diaminooxidase (DAO) (3H-Nuclid) REA</tradeName>
    <deviceName>Diaminooxidase (DAO) (3H-Nuclid) REA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 8220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.788Z</lastUpdated>
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    <udiDi>04050598185005</udiDi>
    <basicUdiDi>B-04050598185005</basicUdiDi>
    <tradeName>IDK® DAO ELISA</tradeName>
    <deviceName>IDK® DAO ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 8500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.758Z</lastUpdated>
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    <udiDi>04050598185104</udiDi>
    <basicUdiDi>B-04050598185104</basicUdiDi>
    <tradeName>IDK® Diaminooxidase (DAO) (1-Punkt-Kalibrierung) ELISA</tradeName>
    <deviceName>IDK® Diaminooxidase (DAO) (1-Punkt-Kalibrierung) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 8510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.727Z</lastUpdated>
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    <udiDi>05032384011872</udiDi>
    <basicUdiDi>5032384NitrocefinRecFldZF</basicUdiDi>
    <tradeName>NITROCEFIN + RECONSTITUTION FLUID</tradeName>
    <deviceName>NITROCEFIN + RECONSTITUTION FLUID</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR0112C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:38.465Z</lastUpdated>
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    <udiDi>05032384011889</udiDi>
    <basicUdiDi>5032384BrdSpecBetaLact6Q</basicUdiDi>
    <tradeName>BROAD SPECTRUM BETA-LACTAMASE MIXTURE</tradeName>
    <deviceName>BROAD SPECTRUM BETA-LACTAMASE MIXTURE</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR0113E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:38.426Z</lastUpdated>
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    <udiDi>05032384013944</udiDi>
    <basicUdiDi>5032384Penase1Vial8X</basicUdiDi>
    <tradeName>PENASE</tradeName>
    <deviceName>PENASE</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR0129B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:37.764Z</lastUpdated>
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    <tradeName>EpiScreen Plus Reagent 1</tradeName>
    <deviceName>EpiScreen Plus</deviceName>
    <manufacturerName>FertiPro</manufacturerName>
    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPI_PLUS_1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:59:52.539Z</lastUpdated>
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    <udiDi>05411967000012</udiDi>
    <basicUdiDi>5411967EPIP1VD</basicUdiDi>
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    <deviceName>EpiScreen Plus</deviceName>
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    <manufacturerSrn>BE-MF-000000313</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPI_PLUS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:51:36.680Z</lastUpdated>
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    <tradeName>06977805760252</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Health SwifTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044339</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA05-01-24S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:54:40.272Z</lastUpdated>
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    <tradeName>06977805760269</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Health SwifTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044339</manufacturerSrn>
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    <reference>AA05-01-24S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:54:39.809Z</lastUpdated>
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    <tradeName>Pyridoxal Phosphate Liquid</tradeName>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>60106</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:31:53.122Z</lastUpdated>
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    <tradeName>Enzymatic Creatinine</tradeName>
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    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
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    <reference>OSR61204</reference>
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    <lastUpdated>2026-07-30T17:29:29.692Z</lastUpdated>
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    <tradeName>α-AMYLASE</tradeName>
    <deviceName>α-AMYLASE</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6106</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:54.249Z</lastUpdated>
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