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    <basicUdiDi>B-09343044002649</basicUdiDi>
    <tradeName>CRE EU 16-well</tradeName>
    <deviceName>Step 2 Plates for CRE EU 16-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21099P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:41.290Z</lastUpdated>
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    <udiDi>09343044002205</udiDi>
    <basicUdiDi>B-09343044002205</basicUdiDi>
    <tradeName>CRE 16-well</tradeName>
    <deviceName>Step 1 tubes for CRE 16-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21098S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:21.125Z</lastUpdated>
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    <udiDi>09343044002199</udiDi>
    <basicUdiDi>B-09343044002199</basicUdiDi>
    <tradeName>CRE 16-well</tradeName>
    <deviceName>Step 2 Plates for CRE 16-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21098P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:17.122Z</lastUpdated>
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    <udiDi>08809240103845</udiDi>
    <basicUdiDi>B-08809240103845</basicUdiDi>
    <tradeName>Allplex™ Entero-DR Assay</tradeName>
    <deviceName>Allplex™ Entero-DR Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR10384Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:54.792Z</lastUpdated>
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    <udiDi>08809240101070</udiDi>
    <basicUdiDi>B-08809240101070</basicUdiDi>
    <tradeName>Allplex™ Entero-DR Assay</tradeName>
    <deviceName>Allplex™ Entero-DR Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR9700X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:51.027Z</lastUpdated>
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    <udiDi>08809240101063</udiDi>
    <basicUdiDi>B-08809240101063</basicUdiDi>
    <tradeName>Allplex™ Entero-DR Assay</tradeName>
    <deviceName>Allplex™ Entero-DR Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR9700Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:32.565Z</lastUpdated>
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    <udiDi>08800044300065</udiDi>
    <basicUdiDi>B-08800044300065</basicUdiDi>
    <tradeName>QMAC-dRAST</tradeName>
    <deviceName>QMAC-dRAST GN S17, QMAC-dRAST GP S17, QMAC-dRAST GN E19, QMAC-dRAST GP E19, QMAC-dRAST GN E22</deviceName>
    <manufacturerName>QuantaMatrix Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022784</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QMdRASTN02, QMdRASTP02, QMdRASTN03, QMdRASTP03, QMdRASTN05</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:48.834Z</lastUpdated>
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    <udiDi>08719327498002</udiDi>
    <basicUdiDi>B-08719327498002</basicUdiDi>
    <tradeName>DermaGenius® Resistance Multiplex real-time PCR kit</tradeName>
    <deviceName>DermaGenius® Resistance Multiplex real-time PCR kit</deviceName>
    <manufacturerName>PathoNostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080607</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:49.798Z</lastUpdated>
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    <udiDi>08698898740539</udiDi>
    <basicUdiDi>B-08698898740539</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion VRE QLP 1.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</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>M0630102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:00.459Z</lastUpdated>
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    <udiDi>08698874205137</udiDi>
    <basicUdiDi>B-08698874205137</basicUdiDi>
    <tradeName>CEFTOBIPROLE 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>CEFTOBIPROLE 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD09631</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:12.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698874204475</udiDi>
    <basicUdiDi>B-08698874204475</basicUdiDi>
    <tradeName>AMPICILLIN 2 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>AMPICILLIN 2 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD00190</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:10.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698874204383</udiDi>
    <basicUdiDi>B-08698874204383</basicUdiDi>
    <tradeName>AMOXICILLIN 20 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>AMOXICILLIN 20 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD00403</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:09.789Z</lastUpdated>
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  <row>
    <udiDi>08698874204260</udiDi>
    <basicUdiDi>B-08698874204260</basicUdiDi>
    <tradeName>MEROPENEM/BORONIC ACID 10/400 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>MEROPENEM/BORONIC ACID 10/400 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD05407</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:08.195Z</lastUpdated>
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  <row>
    <udiDi>08698874203843</udiDi>
    <basicUdiDi>B-08698874203843</basicUdiDi>
    <tradeName>AMPICILLIN/DICLOXACILLIN 10/1 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>AMPICILLIN/DICLOXACILLIN 10/1 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD00252</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:06.852Z</lastUpdated>
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  <row>
    <udiDi>08698874203836</udiDi>
    <basicUdiDi>B-08698874203836</basicUdiDi>
    <tradeName>AZLOCILLIN 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>AZLOCILLIN 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD00505</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:04.196Z</lastUpdated>
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    <udiDi>08698874203584</udiDi>
    <basicUdiDi>B-08698874203584</basicUdiDi>
    <tradeName>EDTA 930 µg TEST DISCS</tradeName>
    <deviceName>EDTA 930 µg TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD03467</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:03.811Z</lastUpdated>
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  <row>
    <udiDi>08698874203577</udiDi>
    <basicUdiDi>B-08698874203577</basicUdiDi>
    <tradeName>EDTA 750 µg TEST DISCS</tradeName>
    <deviceName>EDTA 750 µg TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD03465</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:02.419Z</lastUpdated>
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    <udiDi>08698874201894</udiDi>
    <basicUdiDi>B-08698874201894</basicUdiDi>
    <tradeName>AMOXICILLIN 2 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>AMOXICILLIN 2 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD00402</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:00.706Z</lastUpdated>
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    <udiDi>08698874203317</udiDi>
    <basicUdiDi>B-08698874203317</basicUdiDi>
    <tradeName>AZTREONAM 10 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>AZTREONAM 10 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD00705</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:54:59.358Z</lastUpdated>
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    <udiDi>08698874201900</udiDi>
    <basicUdiDi>B-08698874201900</basicUdiDi>
    <tradeName>AZITHROMYCIN 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>AZITHROMYCIN 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD00501</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:54:58.578Z</lastUpdated>
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