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<eudamedExport entity="devices">
  <row>
    <udiDi>04056719001551</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Vacuum Cushion Plus M (1.4 L)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-213</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001568</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Vacuum Cushion Plus S (0.8 L)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-214</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001575</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Vacuum Pump</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001728</udiDi>
    <basicUdiDi>04056719BUDI0000000001HU</basicUdiDi>
    <tradeName>BodyFIX Hygienic Drape Manifold Tube (1x15000 mm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10102-310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001735</udiDi>
    <basicUdiDi>04056719BUDI0000000001HU</basicUdiDi>
    <tradeName>BodyFIX Hygienic Drape Manifold Cushion</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10102-311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001759</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Mouthpiece Small</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001766</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Mouthpiece Medium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-326</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001773</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Mouthpiece Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-327</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001780</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Mouthpiece Small P2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-328</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001797</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Mouthpiece X-Large P2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001933</udiDi>
    <basicUdiDi>04056719BUDI0000000001HU</basicUdiDi>
    <tradeName>BodyFIX Manifold Cushion 400 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10102-232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001940</udiDi>
    <basicUdiDi>04056719BUDI0000000001HU</basicUdiDi>
    <tradeName>BodyFIX Manifold Cushion 500 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10102-233</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719002060</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Thermoplastic Mask Head (10 PCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719002077</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Thermoplastic Mask Nose (10 PCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719002084</udiDi>
    <basicUdiDi>04056719BUDI0000000002HW</basicUdiDi>
    <tradeName>Fraxion Thermoplastic Mask Single Layer (10 PCS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10106-302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:24:38.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850012936268</udiDi>
    <basicUdiDi>0850012936EV8U</basicUdiDi>
    <tradeName>EVAC-U-SPLINT Small Extremity Splint with Side Release Buckle Straps</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tri-Tech Forensics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024012</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV 101SR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:07.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850012936275</udiDi>
    <basicUdiDi>0850012936EV8U</basicUdiDi>
    <tradeName>EVAC-U-SPLINT - Medium Extremity Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tri-Tech Forensics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024012</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV 102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:07.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850012936282</udiDi>
    <basicUdiDi>0850012936EV8U</basicUdiDi>
    <tradeName>EVAC-U-SPLINT Medium  Extremity Splint with Side Release Buckle Straps</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tri-Tech Forensics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024012</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV 102SR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:07.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850012936299</udiDi>
    <basicUdiDi>0850012936EV8U</basicUdiDi>
    <tradeName>EVAC-U-SPLINT - Large Extremity Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tri-Tech Forensics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024012</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV 103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:07.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850012936305</udiDi>
    <basicUdiDi>0850012936EV8U</basicUdiDi>
    <tradeName>EVAC-U-SPLINT Large Extremity Splint with Side Release Buckle Straps</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tri-Tech Forensics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024012</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV 103SR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:47:07.668Z</lastUpdated>
  </row>
</eudamedExport>