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<eudamedExport entity="devices">
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    <udiDi>08052276022936</udiDi>
    <basicUdiDi>8052276FT0004ID3CZ</basicUdiDi>
    <tradeName>Laser Fiber 20G Straight Illuminated - Connector DRC - A</tradeName>
    <deviceName>Laser Fiber Illuminated/Fibre Laser Illuminate</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0430/DRC-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:19.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276022929</udiDi>
    <basicUdiDi>8052276FT0004ID4D3</basicUdiDi>
    <tradeName>Laser Fiber 20G Straight - Connector DRC</tradeName>
    <deviceName>Fibre laser/ Laser Fiber</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0430/DRC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:18.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276021304</udiDi>
    <basicUdiDi>8052276FT0004ID6D7</basicUdiDi>
    <tradeName>Fiber Optic 20G Standard - Connector A</tradeName>
    <deviceName>Fiber Optics/Fibre ottiche</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0420/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:17.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276020581</udiDi>
    <basicUdiDi>8052276FT0004ID1CV</basicUdiDi>
    <tradeName>Retinal Chandelier 20G with Trocar - Connector A</tradeName>
    <deviceName>Retinal Chandelier/Candelieri</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0414/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:13.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276020147</udiDi>
    <basicUdiDi>8052276FT0004ID7D9</basicUdiDi>
    <tradeName>Retinal illuminated pic 20G - Connector B</tradeName>
    <deviceName>Illuminated Pic/Pic Illuminate</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0407/B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:11.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276019691</udiDi>
    <basicUdiDi>8052276FT0001ID13KT</basicUdiDi>
    <tradeName>High pressure injection/aspiration system for syringe - Connector A</tradeName>
    <deviceName>High pressure injection/aspiration system - Sistema di Iniezione/Aspirazione ad alta pressione</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0383/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:07.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276019660</udiDi>
    <basicUdiDi>8052276FT0001ID15KX</basicUdiDi>
    <tradeName>Air injection tube 70 cm</tradeName>
    <deviceName>Infusion/Aspiration tubing set - Linee per infusione e aspirazione</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0380</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:06.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276019493</udiDi>
    <basicUdiDi>8052276FT0001ID14KV</basicUdiDi>
    <tradeName>Trocar 29G with removable valve</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0343.29/N</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:20:04.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052276001627</udiDi>
    <basicUdiDi>8052276FT0001ID2CA</basicUdiDi>
    <tradeName>Subretinal injection needle 23G tapered to 38G complete with handpiece</tradeName>
    <deviceName>Subretinal injection needle / Ago iniezione sub retinale</deviceName>
    <manufacturerName>AKTIVE SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000007813</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-0468</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:19:58.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016549000</udiDi>
    <basicUdiDi>7290016549EPI-ClearM6</basicUdiDi>
    <tradeName>Epi Clear</tradeName>
    <deviceName>EPI Clear</deviceName>
    <manufacturerName>Orca Surgical</manufacturerName>
    <manufacturerSrn>IL-MF-000012154</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP-04-006</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:20:32.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044451993</udiDi>
    <basicUdiDi>697504445ALCOHOLWELLBV</basicUdiDi>
    <tradeName>Lasek Alcohol Well</tradeName>
    <deviceName>Disposable Ophthalmic Alcohol Well</deviceName>
    <manufacturerName>Sihong Ophsurin Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037458</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R9-A122-H7（SB-14174-1）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:35.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044451962</udiDi>
    <basicUdiDi>697504445DEPRESSORXJ</basicUdiDi>
    <tradeName>Scleral Depressor</tradeName>
    <deviceName>Disposable Ophthalmic Depressor</deviceName>
    <manufacturerName>Sihong Ophsurin Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037458</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6-S126-H2  (SB-35075-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:33.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044451504</udiDi>
    <basicUdiDi>697504445MARKERP5</basicUdiDi>
    <tradeName>Castroviejo Caliper</tradeName>
    <deviceName>Disposable Ophthalmic Marker</deviceName>
    <manufacturerName>Sihong Ophsurin Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037458</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3-S86-H2P（SM-20005-1）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:27.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044451481</udiDi>
    <basicUdiDi>697504445CALLIPER5S</basicUdiDi>
    <tradeName>Braunstein Fixed Caliper</tradeName>
    <deviceName>Disposable Ophthalmic Marker</deviceName>
    <manufacturerName>Sihong Ophsurin Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037458</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F5-S70-H1N（SM-34143-1）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:27.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936055700012</udiDi>
    <basicUdiDi>69360557Eyedrape0019H</basicUdiDi>
    <tradeName>06936055700012</tradeName>
    <deviceName>EYE DRAPE</deviceName>
    <manufacturerName>Shenyang Pacific Medical Products Manufacturing Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003328</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPY-DK：1000×800(mm)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:05:08.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547451336297</udiDi>
    <basicUdiDi>4547451000019Y</basicUdiDi>
    <tradeName>Tanito Micro Hook (TMH®)</tradeName>
    <deviceName>Tanito ab interno Trabeculotomy Micro-hook Disposable, Straight (5 pieces)</deviceName>
    <manufacturerName>Inami &amp; Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000040062</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-2215SET</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:44.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>24058935000534</udiDi>
    <basicUdiDi>4058935-140000-CH</basicUdiDi>
    <tradeName>E7924 25GA Intraocular Bipolar eraser, tapered</tradeName>
    <deviceName>Bipolar Instruments, single-use</deviceName>
    <manufacturerName>Bausch &amp; Lomb GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009142</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E7924</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:39:04.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016549017</udiDi>
    <basicUdiDi>7290016549EPI-ClearM6</basicUdiDi>
    <tradeName>Epi Clear</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orca Surgical</manufacturerName>
    <manufacturerSrn>IL-MF-000012154</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP-04-007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:44:25.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016549048</udiDi>
    <basicUdiDi>7290016549EPI-ClearM6</basicUdiDi>
    <tradeName>Epi Clear</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orca Surgical</manufacturerName>
    <manufacturerSrn>IL-MF-000012154</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP-10-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:44:25.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016549055</udiDi>
    <basicUdiDi>7290016549EPI-ClearM6</basicUdiDi>
    <tradeName>Epi Clear</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orca Surgical</manufacturerName>
    <manufacturerSrn>IL-MF-000012154</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021199</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP-10-007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:44:25.690Z</lastUpdated>
  </row>
</eudamedExport>