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    <lastUpdated>2026-07-08T16:47:22.006Z</lastUpdated>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>AST-NF01</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:21.137Z</lastUpdated>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>AST-GP01</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:21.052Z</lastUpdated>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>697015090000195HS</basicUdiDi>
    <tradeName>AST-ST01</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME1203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:21.005Z</lastUpdated>
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    <udiDi>08594161955610</udiDi>
    <basicUdiDi>B-08594161955610</basicUdiDi>
    <tradeName>GeneProof VRE PCR Kit</tradeName>
    <deviceName>GeneProof VRE PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080604</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VRE/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:40.080Z</lastUpdated>
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    <udiDi>08594161955597</udiDi>
    <basicUdiDi>B-08594161955597</basicUdiDi>
    <tradeName>GeneProof VRE PCR Kit</tradeName>
    <deviceName>GeneProof VRE PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080604</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VRE/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:38.488Z</lastUpdated>
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    <udiDi>08588007926872</udiDi>
    <basicUdiDi>B-08588007926872</basicUdiDi>
    <tradeName>08588007926872</tradeName>
    <deviceName>NEO</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6040</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:29.691Z</lastUpdated>
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    <udiDi>08588007926865</udiDi>
    <basicUdiDi>B-08588007926865</basicUdiDi>
    <tradeName>08588007926865</tradeName>
    <deviceName>BXV disk</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6039</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:28.078Z</lastUpdated>
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    <udiDi>08588007926858</udiDi>
    <basicUdiDi>B-08588007926858</basicUdiDi>
    <tradeName>08588007926858</tradeName>
    <deviceName>BX disk</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6038</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:27.271Z</lastUpdated>
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    <udiDi>08588007926841</udiDi>
    <basicUdiDi>B-08588007926841</basicUdiDi>
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    <deviceName>BV disk</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6037</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:25.669Z</lastUpdated>
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    <deviceName>VAN 5</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:23.269Z</lastUpdated>
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    <deviceName>NYS</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
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    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:21.674Z</lastUpdated>
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    <deviceName>AMB</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-07T22:27:20.866Z</lastUpdated>
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    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:19.274Z</lastUpdated>
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    <deviceName>CLO</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6032</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:27:16.867Z</lastUpdated>
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