<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00844505008136</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>ALTO CUTTER WITHOUT RING</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>912</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505009010</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>CARTILAGE MICROTOME MODULE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505009041</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>CARTILAGE MICROTOME STERILIZATION TRAY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990-005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505009911</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>RIVAS SUCTION ELEVATOR, 165MM LENGTH STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505009928</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>SUCTION ROUND KNIFE, 1.0MM DIAMETER 165MM LENGTH STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505009935</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>SUCTION ROUND KNIFE, 1.5MM DIAMETER 165MM LENGTH STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505009973</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>MICRO DISSECTOR FOR EAR DRUM 165MM LENGTH STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505009980</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>MICRO DISSECTOR FOR SINUS TYMPANI 165MM LENGTH STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505010283</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>OLSON MICRO NEEDLE, SLIGHTYLY CURVED, SS W/ DIAMOND-COATING</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505010290</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>OLSON MICRO HOOK, ANGLED 45°, 3.0MM, SS W/ DIAMOND-COATING</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505010399</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>CARTLIAGE MICROTOME HANDLE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505010405</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>CARTILAGE MICROTOME TISSUE SUPPORT DIAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505010412</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>OLSON MICRO DISSECTOR DOUBLE-ENDED, ANGLED 45°, 2.0MM X 4.0MM, SS W/ DIAMOND-COATING</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT SURGERY DISSECTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505010498</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>MCMENOMEY REVERSE ALLIGATOR FORCEPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>908</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505010917</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>CARLSON-HAYNES UNIVERSAL OTOLOGIC RETRACTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>991-MC1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505011365</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>Suction Adapter Rotatable 360°</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-851-00C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505011945</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>EndoEar™ SUCTION STRAIGHT, 3 FR STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.80.03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505011952</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>EndoEar™ SUCTION STRAIGHT, 5 FR STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.80.05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505011969</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>EndoEar™ SUCTION STRAIGHT, 7 FR STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.80.07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844505011976</udiDi>
    <basicUdiDi>08445050023LG</basicUdiDi>
    <tradeName>EndoEar™ SUCTION STRAIGHT, 20 GA STAINLESS STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grace Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026047</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.80.20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.336Z</lastUpdated>
  </row>
</eudamedExport>