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    <deviceName></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>UNKNOWN</legislation>
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    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002308-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:59.417Z</lastUpdated>
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    <basicUdiDi>69449040004JG6PD*******C3</basicUdiDi>
    <tradeName>Glucose-6-Phosphate Dehydrogenase (G6PD) Kit (UV Enzymatic Method)</tradeName>
    <deviceName></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>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-009264-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:24.761Z</lastUpdated>
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    <udiDi>04050598000490</udiDi>
    <basicUdiDi>B-04050598000490</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>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6830</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:48.606Z</lastUpdated>
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    <udiDi>04050598000506</udiDi>
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    <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>
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    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6831</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:47.006Z</lastUpdated>
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    <udiDi>04050598000483</udiDi>
    <basicUdiDi>B-04050598000483</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>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6841</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:44.618Z</lastUpdated>
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    <udiDi>04050598000377</udiDi>
    <basicUdiDi>B-04050598000377</basicUdiDi>
    <tradeName>DAO-REA (3H)</tradeName>
    <deviceName>DAO-REA (3H)</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 8220.2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:16.530Z</lastUpdated>
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    <udiDi>06977805760238</udiDi>
    <basicUdiDi>697780576HSTAALIBMG6J</basicUdiDi>
    <tradeName>Mycobacterium Multiplex-PCR Library Pre Kit</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>2026-07-02T19:59:37.248Z</lastUpdated>
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    <udiDi>06977805760191</udiDi>
    <basicUdiDi>697780576HSTAALIBMDK</basicUdiDi>
    <tradeName>Mycobacterium Multiplex-PCR Library Pre Kit</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>2026-07-02T19:59:36.456Z</lastUpdated>
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    <udiDi>06975769080010</udiDi>
    <basicUdiDi>697576908PWC3LP1DA</basicUdiDi>
    <tradeName>06975769080010</tradeName>
    <deviceName>Chitinase-3-like protein 1 (kit) （Colloidal Gold）</deviceName>
    <manufacturerName>Hangzhou Proprium Biotech Co.Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000035883</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:45:09.107Z</lastUpdated>
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    <udiDi>05204309171484</udiDi>
    <basicUdiDi>5204309000004NJ</basicUdiDi>
    <tradeName>ADA 2</tradeName>
    <deviceName>ADA 2</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1415-0902</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:57.282Z</lastUpdated>
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    <udiDi>05204309152667</udiDi>
    <basicUdiDi>5204309000003NG</basicUdiDi>
    <tradeName>ADA</tradeName>
    <deviceName>ADA</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1419-0900</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:40.391Z</lastUpdated>
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    <udiDi>05204309132003</udiDi>
    <basicUdiDi>5204309000063P2</basicUdiDi>
    <tradeName>ADA &amp; ADA2</tradeName>
    <deviceName>ADA &amp; ADA2</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0907</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:38.954Z</lastUpdated>
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    <udiDi>04050598013971</udiDi>
    <basicUdiDi>4050598IALCIntolPY</basicUdiDi>
    <tradeName>IDK® DAO ELISA</tradeName>
    <deviceName>IDK® DAO ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y8500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:29.921Z</lastUpdated>
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    <udiDi>03532678593180</udiDi>
    <basicUdiDi>353267F00128P8A</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Sample Treatment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150063</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:19.441Z</lastUpdated>
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    <udiDi>03532678592077</udiDi>
    <basicUdiDi>353267F00061P82</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Lysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150059_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:14.637Z</lastUpdated>
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    <udiDi>08904226000023</udiDi>
    <basicUdiDi>8904226096MB100YZ</basicUdiDi>
    <tradeName>08904226000023</tradeName>
    <deviceName>MBK G6PD</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
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    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96MB100-10, 96MB100-10CC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:17.388Z</lastUpdated>
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    <tradeName>BIOSYNEX AMPLIQUICK Lysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150059_SEC02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:40:51.618Z</lastUpdated>
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    <tradeName>BIOSYNEX AMPLIQUICK Lysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <reference>3150059_BLK100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:40:51.602Z</lastUpdated>
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    <udiDi>06947145561239</udiDi>
    <basicUdiDi>69471455544WL</basicUdiDi>
    <tradeName>Biossays α-L-Fucosidase (CNPF)</tradeName>
    <deviceName>α-L-Fucosidase (CNPF)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130502013A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:20:42.299Z</lastUpdated>
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    <basicUdiDi>69471455544WL</basicUdiDi>
    <tradeName>Biossays α-L-Fucosidase (CNPF)</tradeName>
    <deviceName>α-L-Fucosidase (CNPF)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>130502013S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:20:41.138Z</lastUpdated>
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