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    <deviceName>SCANLAN® DeBakey 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>3003-418</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:49.780Z</lastUpdated>
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    <basicUdiDi>B-00846159003246</basicUdiDi>
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    <deviceName>SCANLAN® DeBakey 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>3003-416</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:48.983Z</lastUpdated>
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    <basicUdiDi>B-00846159003239</basicUdiDi>
    <tradeName>00846159003239</tradeName>
    <deviceName>SCANLAN® DeBakey 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>3003-414</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:47.393Z</lastUpdated>
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    <deviceName>SCANLAN® DeBakey 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>3003-412</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:44.986Z</lastUpdated>
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    <udiDi>00846159003215</udiDi>
    <basicUdiDi>B-00846159003215</basicUdiDi>
    <tradeName>00846159003215</tradeName>
    <deviceName>SCANLAN® Mayo‑Hegar 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>3003-408</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:43.476Z</lastUpdated>
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    <udiDi>00846159003208</udiDi>
    <basicUdiDi>B-00846159003208</basicUdiDi>
    <tradeName>00846159003208</tradeName>
    <deviceName>SCANLAN® Mayo‑Hegar 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>3003-406</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:41.782Z</lastUpdated>
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    <udiDi>00846159003192</udiDi>
    <basicUdiDi>B-00846159003192</basicUdiDi>
    <tradeName>00846159003192</tradeName>
    <deviceName>SCANLAN® Mayo‑Hegar 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>3003-404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:40.175Z</lastUpdated>
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    <udiDi>00846159003185</udiDi>
    <basicUdiDi>B-00846159003185</basicUdiDi>
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    <deviceName>SCANLAN® Mayo‑Hegar 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>3003-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:37.769Z</lastUpdated>
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    <udiDi>00846159003178</udiDi>
    <basicUdiDi>B-00846159003178</basicUdiDi>
    <tradeName>00846159003178</tradeName>
    <deviceName>SCANLAN® Puskas™ 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>3003-391</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:36.182Z</lastUpdated>
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    <udiDi>00846159003161</udiDi>
    <basicUdiDi>B-00846159003161</basicUdiDi>
    <tradeName>00846159003161</tradeName>
    <deviceName>SCANLAN® Puskas™ 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>3003-390</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:35.366Z</lastUpdated>
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    <udiDi>00846159003154</udiDi>
    <basicUdiDi>B-00846159003154</basicUdiDi>
    <tradeName>00846159003154</tradeName>
    <deviceName>SCANLAN® Puskas™ 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>3003-381</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:33.768Z</lastUpdated>
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    <udiDi>00846159003147</udiDi>
    <basicUdiDi>B-00846159003147</basicUdiDi>
    <tradeName>00846159003147</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>3003-267</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:31.376Z</lastUpdated>
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    <udiDi>00846159003130</udiDi>
    <basicUdiDi>B-00846159003130</basicUdiDi>
    <tradeName>00846159003130</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>3003-265</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:29.789Z</lastUpdated>
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    <udiDi>00846159003123</udiDi>
    <basicUdiDi>B-00846159003123</basicUdiDi>
    <tradeName>00846159003123</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>3003-263</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:28.969Z</lastUpdated>
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    <udiDi>00846159003116</udiDi>
    <basicUdiDi>B-00846159003116</basicUdiDi>
    <tradeName>00846159003116</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>3003-261</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:27.368Z</lastUpdated>
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    <udiDi>00846159003109</udiDi>
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    <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>
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    <legislation>MDD</legislation>
    <emdnCode>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-243</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:24.169Z</lastUpdated>
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    <deviceName>SCANLAN® Jacobson Micro Needle Holder</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>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-239</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:22.563Z</lastUpdated>
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    <deviceName>SCANLAN® Jacobson Micro Needle Holder</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>L0205</emdnCode>
    <emdnDescription>NEEDLE HOLDERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003-237</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:21.770Z</lastUpdated>
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    <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>3003-236</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:20.166Z</lastUpdated>
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    <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>3003-235</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:44:17.778Z</lastUpdated>
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