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    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:18:40.580Z</lastUpdated>
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    <udiDi>06944413816275</udiDi>
    <basicUdiDi>B-06944413816275</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:18:37.581Z</lastUpdated>
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    <udiDi>06944413815254</udiDi>
    <basicUdiDi>B-06944413815254</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:15:09.953Z</lastUpdated>
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    <udiDi>06944413815247</udiDi>
    <basicUdiDi>B-06944413815247</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:15:09.739Z</lastUpdated>
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    <udiDi>06944413815230</udiDi>
    <basicUdiDi>B-06944413815230</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:15:00.472Z</lastUpdated>
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    <udiDi>06944413815223</udiDi>
    <basicUdiDi>B-06944413815223</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:57.451Z</lastUpdated>
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    <udiDi>06944413815216</udiDi>
    <basicUdiDi>B-06944413815216</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:56.751Z</lastUpdated>
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    <udiDi>06944413815209</udiDi>
    <basicUdiDi>B-06944413815209</basicUdiDi>
    <tradeName>Calibrant Fuild Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:54.602Z</lastUpdated>
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    <udiDi>06944413815193</udiDi>
    <basicUdiDi>B-06944413815193</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:48.615Z</lastUpdated>
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    <udiDi>06944413815186</udiDi>
    <basicUdiDi>B-06944413815186</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20CP50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:47.632Z</lastUpdated>
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    <udiDi>06944413807365</udiDi>
    <basicUdiDi>B-06944413807365</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:05:29.756Z</lastUpdated>
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    <udiDi>06944413807341</udiDi>
    <basicUdiDi>B-06944413807341</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:05:27.576Z</lastUpdated>
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    <udiDi>06944413803145</udiDi>
    <basicUdiDi>B-06944413803145</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:49:15.205Z</lastUpdated>
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    <udiDi>06944413803107</udiDi>
    <basicUdiDi>B-06944413803107</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:49:14.494Z</lastUpdated>
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    <udiDi>06944413802599</udiDi>
    <basicUdiDi>B-06944413802599</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:48:22.427Z</lastUpdated>
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    <udiDi>06944413801882</udiDi>
    <basicUdiDi>B-06944413801882</basicUdiDi>
    <tradeName>Calibrant Fluid Pack</tradeName>
    <deviceName>Calibrant Fluid Pack</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:47:02.333Z</lastUpdated>
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    <udiDi>06936595776768</udiDi>
    <basicUdiDi>B-06936595776768</basicUdiDi>
    <tradeName>Electrolyte Multiple Calibrator (Direct Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BZ0129P</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:59:30.806Z</lastUpdated>
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    <tradeName>06935740733700</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:03:27.872Z</lastUpdated>
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    <basicUdiDi>B-06438172403062</basicUdiDi>
    <tradeName>NeoMass AAAC Plus Internal Standard - Labelled Argininosuccinic Acid (ISTD - ASA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710011007</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:41:17.336Z</lastUpdated>
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    <tradeName>NeoMass AAAC Plus Internal Standard - Labelled Succinylacetone (ISTD - SUAC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710011006</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:41:16.129Z</lastUpdated>
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