<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M995609400004003</udiDi>
    <basicUdiDi>B-M995609400004003</basicUdiDi>
    <tradeName>M995609400004003</tradeName>
    <deviceName>DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE DP SB CONTOUR LOWER LEG WITH MATCHING LIMB PROTECTION SLEEVE</deviceName>
    <manufacturerName>Delfi Medical Innovations Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000004434</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139006</emdnCode>
    <emdnDescription>PNEUMATIC TOURNIQUETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60-9400-004-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:00:38.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>M995609400003003</udiDi>
    <basicUdiDi>B-M995609400003003</basicUdiDi>
    <tradeName>M995609400003003</tradeName>
    <deviceName>DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE DUAL PORT SINGLE BLADDER CONTOUR THIGH WITH MATCHING LIMB PROTECTION SLEEVE</deviceName>
    <manufacturerName>Delfi Medical Innovations Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000004434</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139006</emdnCode>
    <emdnDescription>PNEUMATIC TOURNIQUETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60-9400-003-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:00:35.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>M995609400002003</udiDi>
    <basicUdiDi>B-M995609400002003</basicUdiDi>
    <tradeName>M995609400002003</tradeName>
    <deviceName>DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE DUAL PORT SINGLE BLADDER CONTOUR ARM WITH MATCHING LIMB PROTECTION SLEEVE</deviceName>
    <manufacturerName>Delfi Medical Innovations Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000004434</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139006</emdnCode>
    <emdnDescription>PNEUMATIC TOURNIQUETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60-9400-002-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:00:34.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>M995609300011003</udiDi>
    <basicUdiDi>B-M995609300011003</basicUdiDi>
    <tradeName>M995609300011003</tradeName>
    <deviceName>DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE DUAL PORT DUAL BLADDER CONTOUR (IVRA) ARM WITH MATCHING LIMB PROTECTION SLEEVE</deviceName>
    <manufacturerName>Delfi Medical Innovations Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000004434</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139006</emdnCode>
    <emdnDescription>PNEUMATIC TOURNIQUETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60-9300-011-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:00:33.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>M995609300004003</udiDi>
    <basicUdiDi>B-M995609300004003</basicUdiDi>
    <tradeName>M995609300004003</tradeName>
    <deviceName>DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE SP SB CONTOUR LOWER LEG WITH MATCHING LIMB PROTECTION SLEEVE</deviceName>
    <manufacturerName>Delfi Medical Innovations Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000004434</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139006</emdnCode>
    <emdnDescription>PNEUMATIC TOURNIQUETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60-9300-004-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:00:32.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>M995609300003003</udiDi>
    <basicUdiDi>B-M995609300003003</basicUdiDi>
    <tradeName>M995609300003003</tradeName>
    <deviceName>DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE SINGLE PORT SINGLE BLADDER CONTOUR THIGH WITH MATCHING LIMB PROTECTION SLEEVE</deviceName>
    <manufacturerName>Delfi Medical Innovations Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000004434</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139006</emdnCode>
    <emdnDescription>PNEUMATIC TOURNIQUETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60-9300-003-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:00:28.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>M995609300002003</udiDi>
    <basicUdiDi>B-M995609300002003</basicUdiDi>
    <tradeName>M995609300002003</tradeName>
    <deviceName>DELFI VARI-FIT TOURNIQUET CUFF SINGLE USE SINGLE PORT SINGLE BLADDER CONTOUR ARM WITH MATCHING LIMB PROTECTION SLEEVE</deviceName>
    <manufacturerName>Delfi Medical Innovations Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000004434</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139006</emdnCode>
    <emdnDescription>PNEUMATIC TOURNIQUETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60-9300-002-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:00:27.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F50NTTIPG</udiDi>
    <basicUdiDi>B-F50NTTIPG</basicUdiDi>
    <tradeName>NAVIBLEF TTO INTENSIVE CARE</tradeName>
    <deviceName>NAVIBLEF TTO INTENSIVE CARE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F50NTTI</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:20.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F50NTTDP6</udiDi>
    <basicUdiDi>B-F50NTTDP6</basicUdiDi>
    <tradeName>VIZULIZE - Blepharitis Eyelid foam</tradeName>
    <deviceName>NAVIBLEF TTO DAILY CARE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F50NTTD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:20.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F50NTI6C</udiDi>
    <basicUdiDi>B-F50NTI6C</basicUdiDi>
    <tradeName>LIDBLEF INTENSIVE CARE</tradeName>
    <deviceName>NAVIBLEF TERP INTENSIVE CARE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F50NTI</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:15.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F50NTEDMR</udiDi>
    <basicUdiDi>B-F50NTEDMR</basicUdiDi>
    <tradeName>NAVIBLEF TERP DAILY CARE</tradeName>
    <deviceName>NAVIBLEF TERP DAILY CARE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F50NTED</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:14.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F50NIRX</udiDi>
    <basicUdiDi>B-F50NIRX</basicUdiDi>
    <tradeName>D-F50NIRX</tradeName>
    <deviceName>NAVIBLEF INTENSIVE CARE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F50NI</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:13.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F50NDRM</udiDi>
    <basicUdiDi>B-F50NDRM</basicUdiDi>
    <tradeName>NAVIBLEF  DAILY CARE</tradeName>
    <deviceName>NAVIBLEF DAILY CARE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F50ND</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:12.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15NVT65</udiDi>
    <basicUdiDi>B-D15NVT65</basicUdiDi>
    <tradeName>NAVITAE</tradeName>
    <deviceName>NAVITAE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15NVT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:10.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15NPRL</udiDi>
    <basicUdiDi>B-D15NPRL</basicUdiDi>
    <tradeName>NAVITAE PLUS</tradeName>
    <deviceName>NAVITAE PLUS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15NP</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:09.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15NIR6</udiDi>
    <basicUdiDi>B-D15NIR6</basicUdiDi>
    <tradeName>NAVI INFLA</tradeName>
    <deviceName>NAVI INFLA</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15NI</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:05.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15FRQY</udiDi>
    <basicUdiDi>B-D15FRQY</basicUdiDi>
    <tradeName>FLORAVISION RED EYES</tradeName>
    <deviceName>FLORAVISION RED EYES - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15FR</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:04.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15FIQE</udiDi>
    <basicUdiDi>B-D15FIQE</basicUdiDi>
    <tradeName>NAVIVISION PLUS - IRRITATED EYES</tradeName>
    <deviceName>FLORAVISION IRRITATED EYES - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15FI</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:03.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15FDQ4</udiDi>
    <basicUdiDi>B-D15FDQ4</basicUdiDi>
    <tradeName>NAVIVISION PLUS - TIRED EYES</tradeName>
    <deviceName>FLORAVISION DRY EYES - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15FD</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:03.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D10VXS3</udiDi>
    <basicUdiDi>B-D10VXS3</basicUdiDi>
    <tradeName>VERBALUX PF</tradeName>
    <deviceName>VERBALUX PF</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10VX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:41.194Z</lastUpdated>
  </row>
</eudamedExport>