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    <basicUdiDi>B-09309001216030</basicUdiDi>
    <tradeName>InfectID-BSI B1 Bacterial Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:49.345Z</lastUpdated>
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  <row>
    <udiDi>09309001216047</udiDi>
    <basicUdiDi>B-09309001216047</basicUdiDi>
    <tradeName>InfectID-BSI B2 Bacterial Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:49.058Z</lastUpdated>
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  <row>
    <udiDi>09309001216054</udiDi>
    <basicUdiDi>B-09309001216054</basicUdiDi>
    <tradeName>InfectID-BSI B3 Bacterial Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:48.218Z</lastUpdated>
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  <row>
    <udiDi>09309001216061</udiDi>
    <basicUdiDi>B-09309001216061</basicUdiDi>
    <tradeName>InfectID-BSI B4 Bacterial Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:47.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>09309001216078</udiDi>
    <basicUdiDi>B-09309001216078</basicUdiDi>
    <tradeName>InfectID-BSI B5 Bacterial Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:37.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>09309001216085</udiDi>
    <basicUdiDi>B-09309001216085</basicUdiDi>
    <tradeName>InfectID-BSI B6 Bacterial Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:37.035Z</lastUpdated>
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  <row>
    <udiDi>09309001216092</udiDi>
    <basicUdiDi>B-09309001216092</basicUdiDi>
    <tradeName>InfectID-BSI Y1 Yeast Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:36.784Z</lastUpdated>
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  <row>
    <udiDi>09309001216108</udiDi>
    <basicUdiDi>B-09309001216108</basicUdiDi>
    <tradeName>InfectID-BSI Y2 Yeast Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:36.603Z</lastUpdated>
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  <row>
    <udiDi>09309001216023</udiDi>
    <basicUdiDi>B-09309001216023</basicUdiDi>
    <tradeName>InfectID-Client Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1.1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:36.435Z</lastUpdated>
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  <row>
    <udiDi>07640328070458</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>Klinion® Kliniderm® Super fiber + Antimicrobial Polymer Technology™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40511813</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:46:16.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640328070342</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>Klinion® Kliniderm® Super fiber + Antimicrobial Polymer Technology™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40511814</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:46:03.137Z</lastUpdated>
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    <udiDi>07640328070359</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>Klinion® Kliniderm® Super fiber + Antimicrobial Polymer Technology™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40511815</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:45:51.062Z</lastUpdated>
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  <row>
    <udiDi>07640328070366</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>Klinion® Kliniderm® Super fiber + Antimicrobial Polymer Technology™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40511816</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:45:37.653Z</lastUpdated>
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  <row>
    <udiDi>09309001216115</udiDi>
    <basicUdiDi>B-09309001216115</basicUdiDi>
    <tradeName>InfectID-BSI Y3 Yeast Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T03:51:51.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>09309001216016</udiDi>
    <basicUdiDi>B-09309001216016</basicUdiDi>
    <tradeName>InfectID-BSI Bacterial and Yeast Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1300.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T03:51:34.361Z</lastUpdated>
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    <udiDi>00850055427006</udiDi>
    <basicUdiDi>0850055427HP2000MF</basicUdiDi>
    <tradeName>AquaBeam Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:57.243Z</lastUpdated>
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    <udiDi>00850055427013</udiDi>
    <basicUdiDi>0850055427SC2000MF</basicUdiDi>
    <tradeName>AquaBeam Scope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:57.223Z</lastUpdated>
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    <udiDi>00850055427020</udiDi>
    <basicUdiDi>0850055427AB2000DS</basicUdiDi>
    <tradeName>AquaBeam Robotic System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:57.202Z</lastUpdated>
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    <udiDi>00850055427037</udiDi>
    <basicUdiDi>0850055427HP2000MF</basicUdiDi>
    <tradeName>AquaBeam Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYDRODISSECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:57.179Z</lastUpdated>
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    <udiDi>00850055427044</udiDi>
    <basicUdiDi>08500554273511014D</basicUdiDi>
    <tradeName>Lithotomy Drape</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROCEPT BioRobotics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000015560</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>351101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:57.157Z</lastUpdated>
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