<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00846159000276</udiDi>
    <basicUdiDi>B-00846159000276</basicUdiDi>
    <tradeName>00846159000276</tradeName>
    <deviceName>SCANLAN® SURG‑I‑LOOP® silicone loops</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-80</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:46.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000252</udiDi>
    <basicUdiDi>B-00846159000252</basicUdiDi>
    <tradeName>00846159000252</tradeName>
    <deviceName>SCANLAN® SURG‑I‑LOOP® silicone loops</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-78A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:44.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000245</udiDi>
    <basicUdiDi>B-00846159000245</basicUdiDi>
    <tradeName>00846159000245</tradeName>
    <deviceName>SCANLAN® SURG‑I‑LOOP® silicone loops</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-78</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:43.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000269</udiDi>
    <basicUdiDi>B-00846159000269</basicUdiDi>
    <tradeName>00846159000269</tradeName>
    <deviceName>SCANLAN® SURG‑I‑LOOP® silicone loops</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-79</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:42.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000238</udiDi>
    <basicUdiDi>B-00846159000238</basicUdiDi>
    <tradeName>00846159000238</tradeName>
    <deviceName>SCANLAN® SURG‑I‑LOOP® silicone loops</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-77</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:39.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000221</udiDi>
    <basicUdiDi>B-00846159000221</basicUdiDi>
    <tradeName>00846159000221</tradeName>
    <deviceName>SCANLAN® SURG‑I‑LOOP® silicone loops</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-76</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:24.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000214</udiDi>
    <basicUdiDi>B-00846159000214</basicUdiDi>
    <tradeName>00846159000214</tradeName>
    <deviceName>SCANLAN® SURG‑I‑LOOP® silicone loops</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-75</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:23.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000146</udiDi>
    <basicUdiDi>B-00846159000146</basicUdiDi>
    <tradeName>00846159000146</tradeName>
    <deviceName>Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surf</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-554</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:11.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000139</udiDi>
    <basicUdiDi>B-00846159000139</basicUdiDi>
    <tradeName>00846159000139</tradeName>
    <deviceName>Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-541</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:11.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000122</udiDi>
    <basicUdiDi>B-00846159000122</basicUdiDi>
    <tradeName>00846159000122</tradeName>
    <deviceName>Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-540</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:10.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000115</udiDi>
    <basicUdiDi>B-00846159000115</basicUdiDi>
    <tradeName>00846159000115</tradeName>
    <deviceName>Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping pr</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-534</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:09.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000108</udiDi>
    <basicUdiDi>B-00846159000108</basicUdiDi>
    <tradeName>00846159000108</tradeName>
    <deviceName>Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping pr</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-533</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:05.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000092</udiDi>
    <basicUdiDi>B-00846159000092</basicUdiDi>
    <tradeName>00846159000092</tradeName>
    <deviceName>Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping pr</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-532</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:04.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000085</udiDi>
    <basicUdiDi>B-00846159000085</basicUdiDi>
    <tradeName>00846159000085</tradeName>
    <deviceName>Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping pr</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-531</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:03.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000078</udiDi>
    <basicUdiDi>B-00846159000078</basicUdiDi>
    <tradeName>00846159000078</tradeName>
    <deviceName>Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping pr</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-530</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:21:03.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000061</udiDi>
    <basicUdiDi>B-00846159000061</basicUdiDi>
    <tradeName>00846159000061</tradeName>
    <deviceName>Scanlan® VASCU-STATT® approximator single-use bulldog clamp</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-507</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:59.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000054</udiDi>
    <basicUdiDi>B-00846159000054</basicUdiDi>
    <tradeName>00846159000054</tradeName>
    <deviceName>Scanlan® VASCU-STATT® single-use bulldog clamp</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-505</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:58.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000047</udiDi>
    <basicUdiDi>B-00846159000047</basicUdiDi>
    <tradeName>00846159000047</tradeName>
    <deviceName>Scanlan® VASCU-STATT® single-use bulldog clamp</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:57.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000030</udiDi>
    <basicUdiDi>B-00846159000030</basicUdiDi>
    <tradeName>00846159000030</tradeName>
    <deviceName>Scanlan® VASCU-STATT® single-use bulldog clamp</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:56.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159000023</udiDi>
    <basicUdiDi>B-00846159000023</basicUdiDi>
    <tradeName>00846159000023</tradeName>
    <deviceName>Scanlan® VASCU-STATT® single-use bulldog clamp</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0699</emdnCode>
    <emdnDescription>CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:52.685Z</lastUpdated>
  </row>
</eudamedExport>