<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00310866000671</udiDi>
    <basicUdiDi>03108669001HF</basicUdiDi>
    <tradeName>R-55, Standard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000688</udiDi>
    <basicUdiDi>03108669001HF</basicUdiDi>
    <tradeName>R-55A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000695</udiDi>
    <basicUdiDi>03108669001HF</basicUdiDi>
    <tradeName>Guyer 7A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26141</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000718</udiDi>
    <basicUdiDi>03108669001HF</basicUdiDi>
    <tradeName>PT-55</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26135</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000725</udiDi>
    <basicUdiDi>03108669002HH</basicUdiDi>
    <tradeName>MicroGrip Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000732</udiDi>
    <basicUdiDi>03108669002HH</basicUdiDi>
    <tradeName>Retrax Cord Cutter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL SCISSORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000749</udiDi>
    <basicUdiDi>03108669002HH</basicUdiDi>
    <tradeName>C-IPC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000756</udiDi>
    <basicUdiDi>03108669002HH</basicUdiDi>
    <tradeName>C-Plugger</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000763</udiDi>
    <basicUdiDi>03108669002HH</basicUdiDi>
    <tradeName>C-IPC Off Angle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL RESTORATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26155</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000800</udiDi>
    <basicUdiDi>03108663001G5</basicUdiDi>
    <tradeName>Retrax Pellets</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000879</udiDi>
    <basicUdiDi>03108665001GK</basicUdiDi>
    <tradeName>Retrax Gel AS 30g Jar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866000909</udiDi>
    <basicUdiDi>03108665004GR</basicUdiDi>
    <tradeName>Retrax Gel FS 30g Jar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15710</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001449</udiDi>
    <basicUdiDi>03108666001GS</basicUdiDi>
    <tradeName>Disposable Foam Fluoride Tray</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001456</udiDi>
    <basicUdiDi>03108666001GS</basicUdiDi>
    <tradeName>Disposable Foam Fluoride Tray (Medium)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23705</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001463</udiDi>
    <basicUdiDi>03108666001GS</basicUdiDi>
    <tradeName>Disposable Foam Fluoride Tray (Large)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23710</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001470</udiDi>
    <basicUdiDi>03108666001GS</basicUdiDi>
    <tradeName>Isolator Disposable Cotton Roll Holder 50 Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL COTTON ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001487</udiDi>
    <basicUdiDi>03108666001GS</basicUdiDi>
    <tradeName>Isolator Disposable Cotton Roll Holder 10 Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL COTTON ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001555</udiDi>
    <basicUdiDi>03108666001GS</basicUdiDi>
    <tradeName>Isolator Disposable Cotton Roll Holder, 100 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL COTTON ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001678</udiDi>
    <basicUdiDi>03108669002HH</basicUdiDi>
    <tradeName>Retrax Tweezer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL SURGERY FORCEPS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26170</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>00310866001685</udiDi>
    <basicUdiDi>03108665002GM</basicUdiDi>
    <tradeName>Retrax AS Solution 15mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pascal Company Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032036</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:14:02.252Z</lastUpdated>
  </row>
</eudamedExport>