<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00846159010756</udiDi>
    <basicUdiDi>B-00846159010756</basicUdiDi>
    <tradeName>00846159010756</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>3003-442N</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:30.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010749</udiDi>
    <basicUdiDi>B-00846159010749</basicUdiDi>
    <tradeName>00846159010749</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>3003-438</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:29.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010732</udiDi>
    <basicUdiDi>B-00846159010732</basicUdiDi>
    <tradeName>00846159010732</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>3003-436</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:28.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010725</udiDi>
    <basicUdiDi>B-00846159010725</basicUdiDi>
    <tradeName>00846159010725</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>3003-434N</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:28.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010718</udiDi>
    <basicUdiDi>B-00846159010718</basicUdiDi>
    <tradeName>00846159010718</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>3003-432</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:24.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010701</udiDi>
    <basicUdiDi>B-00846159010701</basicUdiDi>
    <tradeName>00846159010701</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>3003-430N</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:23.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010695</udiDi>
    <basicUdiDi>B-00846159010695</basicUdiDi>
    <tradeName>00846159010695</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>3003-430</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:22.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010688</udiDi>
    <basicUdiDi>B-00846159010688</basicUdiDi>
    <tradeName>00846159010688</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>3003-428</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:21.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010671</udiDi>
    <basicUdiDi>B-00846159010671</basicUdiDi>
    <tradeName>00846159010671</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>3003-426</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:17.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010664</udiDi>
    <basicUdiDi>B-00846159010664</basicUdiDi>
    <tradeName>00846159010664</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>3003-424</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:16.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010657</udiDi>
    <basicUdiDi>B-00846159010657</basicUdiDi>
    <tradeName>00846159010657</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>3003-418</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:16.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010640</udiDi>
    <basicUdiDi>B-00846159010640</basicUdiDi>
    <tradeName>00846159010640</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>3003-416</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:15.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010633</udiDi>
    <basicUdiDi>B-00846159010633</basicUdiDi>
    <tradeName>00846159010633</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>3003-414</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:11.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010626</udiDi>
    <basicUdiDi>B-00846159010626</basicUdiDi>
    <tradeName>00846159010626</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>3003-412</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:09.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010619</udiDi>
    <basicUdiDi>B-00846159010619</basicUdiDi>
    <tradeName>00846159010619</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>3003-408</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:08.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010602</udiDi>
    <basicUdiDi>B-00846159010602</basicUdiDi>
    <tradeName>00846159010602</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>3003-406</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:08.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010596</udiDi>
    <basicUdiDi>B-00846159010596</basicUdiDi>
    <tradeName>00846159010596</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>3003-404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:13:51.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010589</udiDi>
    <basicUdiDi>B-00846159010589</basicUdiDi>
    <tradeName>00846159010589</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>3003-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:13:51.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010572</udiDi>
    <basicUdiDi>B-00846159010572</basicUdiDi>
    <tradeName>00846159010572</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>3003-397</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:13:47.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010565</udiDi>
    <basicUdiDi>B-00846159010565</basicUdiDi>
    <tradeName>00846159010565</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>3003-393</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:13:46.386Z</lastUpdated>
  </row>
</eudamedExport>