<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00846159021028</udiDi>
    <basicUdiDi>B-00846159021028</basicUdiDi>
    <tradeName>00846159021028</tradeName>
    <deviceName>SCANLAN® Bailey Pediatric 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>8008-212</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:45:35.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159021011</udiDi>
    <basicUdiDi>B-00846159021011</basicUdiDi>
    <tradeName>00846159021011</tradeName>
    <deviceName>SCANLAN® Chaux Valve 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>8008-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:45:34.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159013092</udiDi>
    <basicUdiDi>B-00846159013092</basicUdiDi>
    <tradeName>00846159013092</tradeName>
    <deviceName>SCANLAN® Pediatric Titanium 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>8008-52</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:22:52.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010886</udiDi>
    <basicUdiDi>B-00846159010886</basicUdiDi>
    <tradeName>00846159010886</tradeName>
    <deviceName>SCANLAN® Bailey Finochietto Aluminum Pediatric 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>8008-47</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:53.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010879</udiDi>
    <basicUdiDi>B-00846159010879</basicUdiDi>
    <tradeName>00846159010879</tradeName>
    <deviceName>SCANLAN® Bailey Finochietto Titanium Pediatric 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>8008-45</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:49.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010862</udiDi>
    <basicUdiDi>B-00846159010862</basicUdiDi>
    <tradeName>00846159010862</tradeName>
    <deviceName>SCANLAN® Pediatric Titanium 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>8008-43</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:48.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010824</udiDi>
    <basicUdiDi>B-00846159010824</basicUdiDi>
    <tradeName>00846159010824</tradeName>
    <deviceName>SCANLAN® Bryant Mitral Hook</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>8008-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:42.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010817</udiDi>
    <basicUdiDi>B-00846159010817</basicUdiDi>
    <tradeName>00846159010817</tradeName>
    <deviceName>SCANLAN® Bryant Mitral Hook</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>8008-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:41.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010800</udiDi>
    <basicUdiDi>B-00846159010800</basicUdiDi>
    <tradeName>00846159010800</tradeName>
    <deviceName>SCANLAN® lonescu Double Ended Leaflet Valve 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>8008-06</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:40.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010794</udiDi>
    <basicUdiDi>B-00846159010794</basicUdiDi>
    <tradeName>00846159010794</tradeName>
    <deviceName>SCANLAN® lonescu Double Ended Leaflet Valve 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>8008-04</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:36.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159010787</udiDi>
    <basicUdiDi>B-00846159010787</basicUdiDi>
    <tradeName>00846159010787</tradeName>
    <deviceName>SCANLAN® lonescu Double Ended Leaflet Valve 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>8008-02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:14:36.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159007381</udiDi>
    <basicUdiDi>B-00846159007381</basicUdiDi>
    <tradeName>00846159007381</tradeName>
    <deviceName>SCANLAN® Cochran Pediatric 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>1001-14</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:00:30.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159007374</udiDi>
    <basicUdiDi>B-00846159007374</basicUdiDi>
    <tradeName>00846159007374</tradeName>
    <deviceName>SCANLAN® Cochran Pediatric 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>1001-13</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:00:29.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159007367</udiDi>
    <basicUdiDi>B-00846159007367</basicUdiDi>
    <tradeName>00846159007367</tradeName>
    <deviceName>SCANLAN® Cochran Pediatric 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>1001-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:00:25.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159007350</udiDi>
    <basicUdiDi>B-00846159007350</basicUdiDi>
    <tradeName>00846159007350</tradeName>
    <deviceName>SCANLAN® Cochran Pediatric 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>1001-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:00:24.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159007343</udiDi>
    <basicUdiDi>B-00846159007343</basicUdiDi>
    <tradeName>00846159007343</tradeName>
    <deviceName>SCANLAN® Cochran Pediatric 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>1001-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T16:00:24.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G606JSGI9210X</udiDi>
    <basicUdiDi>B-+G606JSGI9210X</basicUdiDi>
    <tradeName>+G606JSGI9210X</tradeName>
    <deviceName>Balfour Retractor 18cm</deviceName>
    <manufacturerName>JALAL SURGICAL</manufacturerName>
    <manufacturerSrn>PK-MF-000035456</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>JS-GI-921</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-01T00:41:02.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111341919</udiDi>
    <basicUdiDi>50554459RETRACTIONG3</basicUdiDi>
    <tradeName>Cottle-Millard Finger Ring Retractor 5 x 12 mm 5.5 cm - 2 1/4"  Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L03140199</emdnCode>
    <emdnDescription>SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE   - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-775-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:39:03.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111341940</udiDi>
    <basicUdiDi>50554459RETRACTIONG3</basicUdiDi>
    <tradeName>Rochard Retractor Fixation Device Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L03140199</emdnCode>
    <emdnDescription>SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE   - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-433-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:39:03.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111341957</udiDi>
    <basicUdiDi>50554459RETRACTIONG3</basicUdiDi>
    <tradeName>Rochard Retractor British Rail Connector 32 x 6 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L03140199</emdnCode>
    <emdnDescription>SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE   - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-433-12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:39:03.029Z</lastUpdated>
  </row>
</eudamedExport>