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    <udiDi>04987274142093</udiDi>
    <basicUdiDi>4987274W0201010101PRMN2</basicUdiDi>
    <tradeName>NS-Prime</tradeName>
    <deviceName>Discrete Clinical Chemistry Analyzer NS-Prime</deviceName>
    <manufacturerName>Otsuka Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000001943</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04987274142093</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:04.498Z</lastUpdated>
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  <row>
    <udiDi>04987274142079</udiDi>
    <basicUdiDi>4987274W0201010101A01EW</basicUdiDi>
    <tradeName>AA01</tradeName>
    <deviceName>Discrete Clinical Chemistry Analyzer AA01</deviceName>
    <manufacturerName>Otsuka Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000001943</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04987274142079</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:03.681Z</lastUpdated>
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    <udiDi>04987035485513</udiDi>
    <basicUdiDi>498703502SG460644FU</basicUdiDi>
    <tradeName>Standard Gas</tradeName>
    <deviceName>Standard Gas</deviceName>
    <manufacturerName>Otsuka Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000001943</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UB-SP-012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:50.084Z</lastUpdated>
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    <udiDi>04987035301615</udiDi>
    <basicUdiDi>498703502AS460644BJ</basicUdiDi>
    <tradeName>POConePlus-AS10</tradeName>
    <deviceName>POConePlus-AS10</deviceName>
    <manufacturerName>Otsuka Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000001943</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03530161</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:49.270Z</lastUpdated>
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  <row>
    <udiDi>04987035301516</udiDi>
    <basicUdiDi>498703502XX460644TU</basicUdiDi>
    <tradeName>POConePlus Infrared Spectrophotometer</tradeName>
    <deviceName>POConePlus Infrared Spectrophotometer</deviceName>
    <manufacturerName>Otsuka Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000001943</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03530151</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:48.470Z</lastUpdated>
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  <row>
    <udiDi>04582246420027</udiDi>
    <basicUdiDi>4582246424406410E5</basicUdiDi>
    <tradeName>Adastand ODT-SC001</tradeName>
    <deviceName>Adastand ODT-SC001</deviceName>
    <manufacturerName>Otsuka Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000001943</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>B0380</emdnCode>
    <emdnDescription>APHERESIS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04582246420027</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:01:13.983Z</lastUpdated>
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  <row>
    <udiDi>04582246420010</udiDi>
    <basicUdiDi>B-04582246420010</basicUdiDi>
    <tradeName>Adamonitor SC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Otsuka Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000001943</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>B0399</emdnCode>
    <emdnDescription>APHERESIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04582246420010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:00:56.919Z</lastUpdated>
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