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    <deviceName>SCANLAN® LEGACY Jacobson Titanium Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-356</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:54.747Z</lastUpdated>
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    <udiDi>00846159031607</udiDi>
    <basicUdiDi>B-00846159031607</basicUdiDi>
    <tradeName>00846159031607</tradeName>
    <deviceName>SCANLAN® LEGACY Jacobson Titanium Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-354</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:53.143Z</lastUpdated>
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    <basicUdiDi>B-00846159031591</basicUdiDi>
    <tradeName>00846159031591</tradeName>
    <deviceName>SCANLAN® LEGACY Jacobson Titanium Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-352</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:52.346Z</lastUpdated>
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    <udiDi>00846159031584</udiDi>
    <basicUdiDi>B-00846159031584</basicUdiDi>
    <tradeName>00846159031584</tradeName>
    <deviceName>SCANLAN® Jacobson Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-247</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:50.744Z</lastUpdated>
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    <udiDi>00846159031553</udiDi>
    <basicUdiDi>B-00846159031553</basicUdiDi>
    <tradeName>00846159031553</tradeName>
    <deviceName>SCANLAN® Finesse Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2926-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:48.358Z</lastUpdated>
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    <udiDi>00846159031577</udiDi>
    <basicUdiDi>B-00846159031577</basicUdiDi>
    <tradeName>00846159031577</tradeName>
    <deviceName>SCANLAN® Jacobson Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-231</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:46.741Z</lastUpdated>
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    <udiDi>00846159031560</udiDi>
    <basicUdiDi>B-00846159031560</basicUdiDi>
    <tradeName>00846159031560</tradeName>
    <deviceName>SCANLAN® Castroviejo Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-91A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:45.941Z</lastUpdated>
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    <udiDi>00846159031546</udiDi>
    <basicUdiDi>B-00846159031546</basicUdiDi>
    <tradeName>00846159031546</tradeName>
    <deviceName>SCANLAN® Finesse Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2925-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:44.340Z</lastUpdated>
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    <udiDi>00846159031539</udiDi>
    <basicUdiDi>B-00846159031539</basicUdiDi>
    <tradeName>00846159031539</tradeName>
    <deviceName>SCANLAN® Heifetz Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2814-04</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:29.090Z</lastUpdated>
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    <udiDi>00846159031522</udiDi>
    <basicUdiDi>B-00846159031522</basicUdiDi>
    <tradeName>00846159031522</tradeName>
    <deviceName>SCANLAN® Heifetz Micro Needle Holder</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2813-04-21C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:28.281Z</lastUpdated>
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    <udiDi>00846159031508</udiDi>
    <basicUdiDi>B-00846159031508</basicUdiDi>
    <tradeName>00846159031508</tradeName>
    <deviceName>SCANLAN® Special Vasculator Dilator</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-450</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:27.482Z</lastUpdated>
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    <udiDi>00846159031492</udiDi>
    <basicUdiDi>B-00846159031492</basicUdiDi>
    <tradeName>00846159031492</tradeName>
    <deviceName>SCANLAN® Vascular Graduated Dilators</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-442</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:23.488Z</lastUpdated>
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    <udiDi>00846159031485</udiDi>
    <basicUdiDi>B-00846159031485</basicUdiDi>
    <tradeName>00846159031485</tradeName>
    <deviceName>SCANLAN® Garrett Vascular Dilator</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-440</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:22.683Z</lastUpdated>
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    <udiDi>00846159031478</udiDi>
    <basicUdiDi>B-00846159031478</basicUdiDi>
    <tradeName>00846159031478</tradeName>
    <deviceName>SCANLAN® Garrett Vascular Dilators</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-422</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:21.885Z</lastUpdated>
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    <udiDi>00846159031461</udiDi>
    <basicUdiDi>B-00846159031461</basicUdiDi>
    <tradeName>00846159031461</tradeName>
    <deviceName>SCANLAN® Garrett Vascular Dilators</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-396</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:21.082Z</lastUpdated>
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    <tradeName>00846159031454</tradeName>
    <deviceName>SCANLAN® Special Garrett Vascular Dilator</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-395</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:17.081Z</lastUpdated>
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    <deviceName>SCANLAN® Special Garrett Vascular Dilator</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-394</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:16.289Z</lastUpdated>
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    <deviceName>SCANLAN® Garrett Vascular Dilators</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-390</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:15.479Z</lastUpdated>
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    <deviceName>SCANLAN® Garrett Vascular Dilators</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-385</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:14.679Z</lastUpdated>
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    <tradeName>00846159031409</tradeName>
    <deviceName>SCANLAN® Tubbs Valve Dilator</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L031102</emdnCode>
    <emdnDescription>EXPLORATION PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-204-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T06:54:10.674Z</lastUpdated>
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