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    <tradeName>HistoCore SPECTRA H&amp;E Staining System S2</tradeName>
    <deviceName>SPECTRA</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3801655</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:48:37.749Z</lastUpdated>
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    <udiDi>00849832013525</udiDi>
    <basicUdiDi>849832029V5</basicUdiDi>
    <tradeName>HistoCore SPECTRA H&amp;E Staining System S2-800</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3801657</reference>
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    <udiDi>00849832013464</udiDi>
    <basicUdiDi>849832029V5</basicUdiDi>
    <tradeName>HistoCore SPECTRA H&amp;E Staining System S1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3801654</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:47:20.961Z</lastUpdated>
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    <udiDi>00849832020523</udiDi>
    <basicUdiDi>849832029V5</basicUdiDi>
    <tradeName>HistoCore SPECTRA H&amp;E Staining System S1-800</tradeName>
    <deviceName>SPECTRA</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3801656</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:14.763Z</lastUpdated>
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    <udiDi>00849832020721</udiDi>
    <basicUdiDi>849832015US</basicUdiDi>
    <tradeName>EA-50</tradeName>
    <deviceName>Cytology Stains</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3801620</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:03:58.572Z</lastUpdated>
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    <udiDi>00849832002901</udiDi>
    <basicUdiDi>849832011UJ</basicUdiDi>
    <tradeName>SelecTech Blue Buffer 8 Concentrate</tradeName>
    <deviceName>Bluing Agent</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3802916</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:59:44.400Z</lastUpdated>
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    <udiDi>00849832014003</udiDi>
    <basicUdiDi>849832011UJ</basicUdiDi>
    <tradeName>Scott’s Tap Water Substitute Working Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3802901E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:44.178Z</lastUpdated>
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    <udiDi>00849832019312</udiDi>
    <basicUdiDi>849832011UJ</basicUdiDi>
    <tradeName>SelecTech Blue Buffer 8 Ready-to-Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3802918</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:39.775Z</lastUpdated>
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    <udiDi>00849832012863</udiDi>
    <basicUdiDi>849832009UX</basicUdiDi>
    <tradeName>Aqueous Eosin 1%</tradeName>
    <deviceName>Eosin</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3801590E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:48:00.512Z</lastUpdated>
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    <udiDi>00630414594972</udiDi>
    <basicUdiDi>0405686900751VP</basicUdiDi>
    <tradeName>ADVIA Autoslide May-Grünwald Giemsa Buffer</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_A.slide May-Grünwald Gie Buff</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10718484</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:04.120Z</lastUpdated>
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    <udiDi>00630414594958</udiDi>
    <basicUdiDi>0405686900839W6</basicUdiDi>
    <tradeName>ADVIA Autoslide May-Grünwald Stain</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_INST_AutoSlide May-Grunwald Stain</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10718482</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:03.320Z</lastUpdated>
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    <udiDi>00630414503936</udiDi>
    <basicUdiDi>0405686900753VT</basicUdiDi>
    <tradeName>ADVIA Autoslide Modified Wright Stain</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_A.slide Modified Wright's Stn</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10327576</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:48:56.127Z</lastUpdated>
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    <udiDi>18430155008382</udiDi>
    <basicUdiDi>8430155PANOPTICORAPIDOHS</basicUdiDi>
    <tradeName>QUICK PANOPTIC KIT (3 x 500 mL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:32.150Z</lastUpdated>
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    <udiDi>18430155009969</udiDi>
    <basicUdiDi>8430155GIEMSARC</basicUdiDi>
    <tradeName>Giemsa Kit (2 x 50 mL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>994305</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:31.767Z</lastUpdated>
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    <udiDi>18430155010552</udiDi>
    <basicUdiDi>8430155PANOPTICORAPIDOHS</basicUdiDi>
    <tradeName>QUICK PANOPTIC KIT(AUTO) (3 x 500 mL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993098</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:31.546Z</lastUpdated>
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    <udiDi>18430155011085</udiDi>
    <basicUdiDi>8430155PANOPTICORAPIDOHS</basicUdiDi>
    <tradeName>SPERM STAIN (3 x 500 mL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>983095</reference>
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    <lastUpdated>2026-07-20T04:36:31.520Z</lastUpdated>
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    <basicUdiDi>8430155PANOPTICORAPIDOHS</basicUdiDi>
    <tradeName>QUICK PANOPTIC KIT (3 x 100 mL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:31.457Z</lastUpdated>
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    <udiDi>08055510564513</udiDi>
    <basicUdiDi>805551056dif_stainTA</basicUdiDi>
    <tradeName>DIF STAIN KIT 3 X 250 ml</tradeName>
    <deviceName>DIF STAIN</deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010301</emdnCode>
    <emdnDescription>HISTO / CYTO STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1526</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:51:42.187Z</lastUpdated>
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    <basicUdiDi>0405686901722VP</basicUdiDi>
    <tradeName>Hematek Stain Pak – Modified Wright’s Stain</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Hematek Modified Wright Stain Pak</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310965</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:15.990Z</lastUpdated>
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    <basicUdiDi>0405686901721VM</basicUdiDi>
    <tradeName>Hematek Stain Pak – Wright-Giemsa Stain</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Hematek Modified W.Giemsa Stain Pak</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10314755</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:12.381Z</lastUpdated>
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