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    <tradeName>ARK Topiramate Assay</tradeName>
    <deviceName>ARK Topiramate Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-05T08:38:52.673Z</lastUpdated>
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    <basicUdiDi>B-00380740102715</basicUdiDi>
    <tradeName>00380740102715</tradeName>
    <deviceName>Theophylline</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <reference>5P06-21</reference>
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    <udiDi>00380740102708</udiDi>
    <basicUdiDi>B-00380740102708</basicUdiDi>
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    <deviceName>Phenytoin</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
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    <deviceName>Phenobarbital</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P07-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:04.361Z</lastUpdated>
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    <udiDi>00380740102685</udiDi>
    <basicUdiDi>B-00380740102685</basicUdiDi>
    <tradeName>00380740102685</tradeName>
    <deviceName>Carbamazepine</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000028203</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P05-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:03.561Z</lastUpdated>
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    <udiDi>08437013457569</udiDi>
    <basicUdiDi>8437013457Promonitor009H7</basicUdiDi>
    <tradeName>Promonitor-VDZ</tradeName>
    <deviceName>Promonitor-VDZ</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5391530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:53.356Z</lastUpdated>
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    <tradeName>Promonitor-ANTI-RTX</tradeName>
    <deviceName>Promonitor-ANTI-RTX</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102080704</emdnCode>
    <emdnDescription>RITUXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:52.565Z</lastUpdated>
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    <tradeName>Promonitor-ANTI-ADL</tradeName>
    <deviceName>Promonitor-ANTI-ADL</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
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    <reference>5090230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:48.541Z</lastUpdated>
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    <tradeName>Promonitor-ADL</tradeName>
    <deviceName>Promonitor-ADL</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080230000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:47.734Z</lastUpdated>
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    <udiDi>08437013457453</udiDi>
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    <tradeName>Promonitor CONTROL-ADL</tradeName>
    <deviceName>Promonitor CONTROL-ADL</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54415C0000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:46.938Z</lastUpdated>
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    <tradeName>Promonitor CONTROL-IFX</tradeName>
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    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54315C0000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:46.140Z</lastUpdated>
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    <udiDi>08437013457408</udiDi>
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    <tradeName>Promonitor-ANTI-VDZ</tradeName>
    <deviceName>Promonitor-ANTI-VDZ</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5401530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:42.140Z</lastUpdated>
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    <udiDi>08437013457392</udiDi>
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    <tradeName>Promonitor-ANTI-UTK</tradeName>
    <deviceName>Promonitor-ANTI-UTK</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5381530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:41.335Z</lastUpdated>
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    <udiDi>08437013457385</udiDi>
    <basicUdiDi>8437013457Promonitor013GW</basicUdiDi>
    <tradeName>Promonitor-UTK</tradeName>
    <deviceName>Promonitor-UTK</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5371530000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:40.534Z</lastUpdated>
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    <tradeName>Promonitor-ANTI-IFX</tradeName>
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    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
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    <lastUpdated>2026-07-03T12:04:39.734Z</lastUpdated>
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    <tradeName>Quantia Digitoxin</tradeName>
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    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>6K40-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:20:52.491Z</lastUpdated>
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    <tradeName>Alinity c Digitoxin Standard</tradeName>
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    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
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    <lastUpdated>2026-07-03T11:20:38.881Z</lastUpdated>
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