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    <tradeName>Tack Endovascular System</tradeName>
    <deviceName>Tack Endovascular System (6F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>156135062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:46.202Z</lastUpdated>
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  <row>
    <udiDi>00863328000165</udiDi>
    <basicUdiDi>B-00863328000165</basicUdiDi>
    <tradeName>Tack Endovascular System (6F, 2.5-6.0mm)</tradeName>
    <deviceName>Tack Endovascular System (6F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>156120062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:45.407Z</lastUpdated>
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  <row>
    <udiDi>00863328000158</udiDi>
    <basicUdiDi>B-00863328000158</basicUdiDi>
    <tradeName>Tack Endovascular System (6F, 2.5-6.0mm)</tradeName>
    <deviceName>Tack Endovascular System (6F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>156080062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:40.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863328000141</udiDi>
    <basicUdiDi>B-00863328000141</basicUdiDi>
    <tradeName>Tack Endovascular System (4F, 1.5-4.5mm)</tradeName>
    <deviceName>Tack Endovascular System (4F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>154150042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:39.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863328000134</udiDi>
    <basicUdiDi>B-00863328000134</basicUdiDi>
    <tradeName>Tack Endovascular System (4F, 1.5-4.5mm)</tradeName>
    <deviceName>Tack Endovascular System (4F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>154090042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:39.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850007350208</udiDi>
    <basicUdiDi>B-00850007350208</basicUdiDi>
    <tradeName>Shaw Scalpel</tradeName>
    <deviceName>Thermal Scalpel P8400 Console</deviceName>
    <manufacturerName>C2Dx Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044935</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12029099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7013-8400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:27.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850003494029</udiDi>
    <basicUdiDi>B-00850003494029</basicUdiDi>
    <tradeName>Tack Endovascular System (6F, 4.0-8.0mm)</tradeName>
    <deviceName>Tack Endovascular System (6F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>206080062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:16.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850003494012</udiDi>
    <basicUdiDi>B-00850003494012</basicUdiDi>
    <tradeName>Tack Endovascular System (6F, 4.0-8.0mm)</tradeName>
    <deviceName>Tack Endovascular System (6F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>206120062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:15.119Z</lastUpdated>
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  <row>
    <udiDi>00850003494005</udiDi>
    <basicUdiDi>B-00850003494005</basicUdiDi>
    <tradeName>Tack Endovascular System (6F, 4.0-8.0mm)</tradeName>
    <deviceName>Tack Endovascular System (6F)</deviceName>
    <manufacturerName>Intact Vascular, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011102</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020102</emdnCode>
    <emdnDescription>NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>206135062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:14.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447018568</udiDi>
    <basicUdiDi>B-00685447018568</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:03.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447018551</udiDi>
    <basicUdiDi>B-00685447018551</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:59.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00685447018544</udiDi>
    <basicUdiDi>B-00685447018544</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:59.079Z</lastUpdated>
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  <row>
    <udiDi>00685447004592</udiDi>
    <basicUdiDi>B-00685447004592</basicUdiDi>
    <tradeName>00685447004592</tradeName>
    <deviceName>RFP-100A Connector Cables</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0317</emdnCode>
    <emdnDescription>GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFX-BAY-TS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:58.270Z</lastUpdated>
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    <udiDi>00685447000969</udiDi>
    <basicUdiDi>B-00685447000969</basicUdiDi>
    <tradeName>00685447000969</tradeName>
    <deviceName>Baylis Medical Company Radiofrequency Puncture Generator</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010999</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFP-100A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:57.479Z</lastUpdated>
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    <udiDi>00844505004893</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>SLIDING MEASURING ROD</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>905</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.851Z</lastUpdated>
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    <udiDi>00844505004909</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>ALTO CUTTER</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>910</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.833Z</lastUpdated>
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    <udiDi>00844505006170</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>MALLEABLE MEASURING ROD</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>915</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.810Z</lastUpdated>
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    <udiDi>00844505006187</udiDi>
    <basicUdiDi>08445050022LE</basicUdiDi>
    <tradeName>MOLDED OTOLOGIC SIZERS POLYPROPYLENE 10 PACK</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>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.784Z</lastUpdated>
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    <udiDi>00844505007139</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>CARTLIAGE MICROTOME</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>990-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.765Z</lastUpdated>
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    <udiDi>00844505008112</udiDi>
    <basicUdiDi>08445050024LJ</basicUdiDi>
    <tradeName>MALLEUS MEASURING ROD</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>901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:34:16.742Z</lastUpdated>
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