<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00846159021370</udiDi>
    <basicUdiDi>B-00846159021370</basicUdiDi>
    <tradeName>00846159021370</tradeName>
    <deviceName>SCANLAN® Variable Suction Non-Rotatable Tips</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>L030101</emdnCode>
    <emdnDescription>SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-957</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:43.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021363</udiDi>
    <basicUdiDi>B-00846159021363</basicUdiDi>
    <tradeName>00846159021363</tradeName>
    <deviceName>SCANLAN® Variable Suction Non-Rotatable Tips</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>L030101</emdnCode>
    <emdnDescription>SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-955</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:39.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021356</udiDi>
    <basicUdiDi>B-00846159021356</basicUdiDi>
    <tradeName>00846159021356</tradeName>
    <deviceName>SCANLAN® Variable Suction Non-Rotatable Tips</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>L030101</emdnCode>
    <emdnDescription>SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-954</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:38.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021349</udiDi>
    <basicUdiDi>B-00846159021349</basicUdiDi>
    <tradeName>00846159021349</tradeName>
    <deviceName>SCANLAN® Variable Suction Non-Rotatable Tips</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>L030101</emdnCode>
    <emdnDescription>SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-953</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:37.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021332</udiDi>
    <basicUdiDi>B-00846159021332</basicUdiDi>
    <tradeName>00846159021332</tradeName>
    <deviceName>SCANLAN® Variable Suction Non-Rotatable Tips</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>L030101</emdnCode>
    <emdnDescription>SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-952</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:36.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021325</udiDi>
    <basicUdiDi>B-00846159021325</basicUdiDi>
    <tradeName>00846159021325</tradeName>
    <deviceName>SCANLAN® Variable Suction Non-Rotatable Tips</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>L030101</emdnCode>
    <emdnDescription>SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-951</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:32.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021264</udiDi>
    <basicUdiDi>B-00846159021264</basicUdiDi>
    <tradeName>00846159021264</tradeName>
    <deviceName>SCANLAN® CardioVasive™ Vascu‑Statt®  Appliers</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-506A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:25.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021257</udiDi>
    <basicUdiDi>B-00846159021257</basicUdiDi>
    <tradeName>00846159021257</tradeName>
    <deviceName>SCANLAN® CardioVasive™ Vascu‑Statt®  Appliers</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-506</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:24.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021240</udiDi>
    <basicUdiDi>B-00846159021240</basicUdiDi>
    <tradeName>00846159021240</tradeName>
    <deviceName>SCANLAN®  CardioVasive™ Jacobson Forceps</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-480</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:24.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021233</udiDi>
    <basicUdiDi>B-00846159021233</basicUdiDi>
    <tradeName>00846159021233</tradeName>
    <deviceName>SCANLAN® CardioVasive™ Chitwood DeBakey Needle Pulling Tissue Forceps</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-466</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:20.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021226</udiDi>
    <basicUdiDi>B-00846159021226</basicUdiDi>
    <tradeName>00846159021226</tradeName>
    <deviceName>SCANLAN® CardioVasive™ Chitwood Jacobson Valve Forceps</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-434R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:19.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021219</udiDi>
    <basicUdiDi>B-00846159021219</basicUdiDi>
    <tradeName>00846159021219</tradeName>
    <deviceName>SCANLAN® CardioVasive™ Chitwood Jacobson Valve Forceps</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-434</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:18.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021202</udiDi>
    <basicUdiDi>B-00846159021202</basicUdiDi>
    <tradeName>00846159021202</tradeName>
    <deviceName>SCANLAN® CardioVasive™ /Thoracoscopic Jacobson DeBakey Forceps</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-422R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:17.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021165</udiDi>
    <basicUdiDi>B-00846159021165</basicUdiDi>
    <tradeName>00846159021165</tradeName>
    <deviceName>SCANLAN® Ochsner Angled Delicate Plane Finder Dissector</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>3003-378</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:13.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021158</udiDi>
    <basicUdiDi>B-00846159021158</basicUdiDi>
    <tradeName>00846159021158</tradeName>
    <deviceName>SCANLAN® Olivecrona Double Ended Dissector</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>3003-354</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:12.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021189</udiDi>
    <basicUdiDi>B-00846159021189</basicUdiDi>
    <tradeName>00846159021189</tradeName>
    <deviceName>SCANLAN® Ochsner Plaque Remover</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-152N</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:12.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021172</udiDi>
    <basicUdiDi>B-00846159021172</basicUdiDi>
    <tradeName>00846159021172</tradeName>
    <deviceName>SCANLAN® Ochsner Plaque Remover</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>L031306</emdnCode>
    <emdnDescription>HEMOSTATIC FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009-150N</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:46:11.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021141</udiDi>
    <basicUdiDi>B-00846159021141</basicUdiDi>
    <tradeName>00846159021141</tradeName>
    <deviceName>SCANLAN® Olivecrona Double Ended Dissector</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>3003-352</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:45:54.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021134</udiDi>
    <basicUdiDi>B-00846159021134</basicUdiDi>
    <tradeName>00846159021134</tradeName>
    <deviceName>SCANLAN® Olivecrona Double Ended Dissector</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>3003-346</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:45:53.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021127</udiDi>
    <basicUdiDi>B-00846159021127</basicUdiDi>
    <tradeName>00846159021127</tradeName>
    <deviceName>SCANLAN® Cooley Sternal Retractor</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>L03140199</emdnCode>
    <emdnDescription>SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE   - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8008-72</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:45:52.815Z</lastUpdated>
  </row>
</eudamedExport>