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    <basicUdiDi>08464050K046CV</basicUdiDi>
    <tradeName>Histo/Zyme</tradeName>
    <deviceName>Histo/Zyme</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K046</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:51:38.695Z</lastUpdated>
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    <udiDi>00846405012480</udiDi>
    <basicUdiDi>08464050K045CT</basicUdiDi>
    <tradeName>Intensi/Fire</tradeName>
    <deviceName>Intensi/Fire</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K045</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:51:23.213Z</lastUpdated>
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    <udiDi>00846405012213</udiDi>
    <basicUdiDi>08464050K044CR</basicUdiDi>
    <tradeName>10X Antigen Retrieval Buffer High pH 10.0</tradeName>
    <deviceName>10x Antigen Retrieval Buffer High pH 10.0</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K044</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:51:20.120Z</lastUpdated>
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    <udiDi>00846405012268</udiDi>
    <basicUdiDi>08464050K043CP</basicUdiDi>
    <tradeName>10X Tris-EDTA Buffer for Heat Induced Epitope Recovery, pH 9.0</tradeName>
    <deviceName>10x Tris-EDTA Buffer for Heat Induced Epitope Recovery, pH 9.0</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K043</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:51:17.030Z</lastUpdated>
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  <row>
    <udiDi>00846405012497</udiDi>
    <basicUdiDi>08464050K042CM</basicUdiDi>
    <tradeName>Elite Mini PAP Pen</tradeName>
    <deviceName>Elite Mini PAP Pen</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:51:13.991Z</lastUpdated>
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  <row>
    <udiDi>00846405012367</udiDi>
    <basicUdiDi>08464050K039CY</basicUdiDi>
    <tradeName>Elite PAP Pen</tradeName>
    <deviceName>Elite PAP Pen</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K039</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:54.722Z</lastUpdated>
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  <row>
    <udiDi>00846405012251</udiDi>
    <basicUdiDi>08464050K038CW</basicUdiDi>
    <tradeName>10X EDTA Buffer for Heat Induced Epitope Recovery, pH 8.0</tradeName>
    <deviceName>10x EDTA Buffer for Heat Induced Epitope Recovery, pH 8.0</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K038</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:51.436Z</lastUpdated>
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  <row>
    <udiDi>00846405016709</udiDi>
    <basicUdiDi>08464050K038500ANP6</basicUdiDi>
    <tradeName>Montage EDTA Antigen Retrieval Solution</tradeName>
    <deviceName>Montage EDTA Antigen Retrieval Solution</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K038-500AN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:48.179Z</lastUpdated>
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  <row>
    <udiDi>00846405012244</udiDi>
    <basicUdiDi>08464050K037CU</basicUdiDi>
    <tradeName>10X Citrate Buffer for Heat Induced Epitope Recovery, pH 8.0</tradeName>
    <deviceName>10x Citrate Buffer for Heat Induced Epitope Recovery, pH 8.0</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K037</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:44.922Z</lastUpdated>
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  <row>
    <udiDi>00846405012237</udiDi>
    <basicUdiDi>08464050K036CS</basicUdiDi>
    <tradeName>10X Citrate Buffer for Heat Induced Epitope Recovery, pH 7.0</tradeName>
    <deviceName>10x Citrate Buffer for Heat Induced Epitope Recovery, pH 7.0</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:28.731Z</lastUpdated>
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  <row>
    <udiDi>00846405012220</udiDi>
    <basicUdiDi>08464050K035CQ</basicUdiDi>
    <tradeName>10X Citrate Buffer for Heat Induced Epitope Recovery, pH 6.0</tradeName>
    <deviceName>10x Citrate Buffer for Heat Induced Epitope Recovery, pH 6.0</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K035</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:22.100Z</lastUpdated>
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  <row>
    <udiDi>00846405016693</udiDi>
    <basicUdiDi>08464050K035500ANMX</basicUdiDi>
    <tradeName>Montage Citrate Antigen Retrieval Solution</tradeName>
    <deviceName>Montage Citrate Antigen Retrieval Solution</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K035-500AN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:18.833Z</lastUpdated>
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  <row>
    <udiDi>00846405012510</udiDi>
    <basicUdiDi>08464050K033CL</basicUdiDi>
    <tradeName>Peroxidase Block</tradeName>
    <deviceName>Peroxidase Block</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K033IVDD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:50:15.574Z</lastUpdated>
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  <row>
    <udiDi>00846405012534</udiDi>
    <basicUdiDi>08464050K030CE</basicUdiDi>
    <tradeName>25X Proteinase K</tradeName>
    <deviceName>25X Proteinase K</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:49:58.997Z</lastUpdated>
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    <udiDi>00846405012404</udiDi>
    <basicUdiDi>08464050K024CK</basicUdiDi>
    <tradeName>Fluoromount™</tradeName>
    <deviceName>Fluoromount</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030706</emdnCode>
    <emdnDescription>MOUNTING MEDIA (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:49:55.500Z</lastUpdated>
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    <udiDi>00846405012299</udiDi>
    <basicUdiDi>08464050K023CH</basicUdiDi>
    <tradeName>Background Blocker</tradeName>
    <deviceName>Background Blocker (1X)</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K023IVDD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:49:52.074Z</lastUpdated>
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    <udiDi>00846405012565</udiDi>
    <basicUdiDi>08464050K013CE</basicUdiDi>
    <tradeName>Tissue Bond™ Reagent</tradeName>
    <deviceName>Tissue Bond Reagent</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:49:48.640Z</lastUpdated>
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    <udiDi>00846405012282</udiDi>
    <basicUdiDi>08464050K011CA</basicUdiDi>
    <tradeName>Alkaline Phosphatase Enhancer</tradeName>
    <deviceName>Alkaline Phosphatase Enhancer</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:49:28.041Z</lastUpdated>
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    <udiDi>00846405012541</udiDi>
    <basicUdiDi>08464050K009CP</basicUdiDi>
    <tradeName>Solution Pepsin</tradeName>
    <deviceName>Solution Pepsin</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:49:24.620Z</lastUpdated>
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    <udiDi>00846405012442</udiDi>
    <basicUdiDi>08464050K005CF</basicUdiDi>
    <tradeName>10X Immuno Wash Buffer</tradeName>
    <deviceName>10X Immuno Wash Buffer</deviceName>
    <manufacturerName>Diagnostic BioSystems</manufacturerName>
    <manufacturerSrn>US-MF-000028606</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-08T05:49:21.193Z</lastUpdated>
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