<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975044451450</udiDi>
    <basicUdiDi>697504445AdjSPECULUMNN</basicUdiDi>
    <tradeName>Adjustable Speculum</tradeName>
    <deviceName>Disposable Ophthalmic speculum</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>Q021107</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-H11-78-14(SO-15034-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:23.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044451399</udiDi>
    <basicUdiDi>697504445SPECULUMLH</basicUdiDi>
    <tradeName>Barraquer Solid Speculum</tradeName>
    <deviceName>Disposable Ophthalmic speculum</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>Q021107</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F4-H11-45-13.5（SO-15015-2）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:22.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044450958</udiDi>
    <basicUdiDi>697504445SCISSORSLU</basicUdiDi>
    <tradeName>Lens Cutter</tradeName>
    <deviceName>Disposable Ophthalmic Scissors</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>Q021103</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F2-A85-H1-15(SS-13080-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:21.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044450743</udiDi>
    <basicUdiDi>697504445HOLDERPH</basicUdiDi>
    <tradeName>Needle Holder</tradeName>
    <deviceName>Disposable Ophthalmic Holder</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>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3 -S140-H11P(SH-12205-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:20.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044450613</udiDi>
    <basicUdiDi>697504445MOSQUITOSG</basicUdiDi>
    <tradeName>Needle Holder</tradeName>
    <deviceName>Disposable Ophthalmic Holder</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>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-C115-H1N(SH-32008-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:16.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044450453</udiDi>
    <basicUdiDi>697504445LENSFORCEPTL</basicUdiDi>
    <tradeName>Lens Forceps</tradeName>
    <deviceName>Disposable Lens Forceps</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>Q021111</emdnCode>
    <emdnDescription>OCULAR IMPLANT INSTRUMENTS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-C115-T3H0N（SF-11282-1）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:15.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044450071</udiDi>
    <basicUdiDi>697504445CHALAZIONCLAMPG7</basicUdiDi>
    <tradeName>Mcpherson Toothed Forceps</tradeName>
    <deviceName>Disposable Ophthalmic Forceps</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>Q021102</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F-A85-T1H1P（SF-11114-2）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:15.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044450026</udiDi>
    <basicUdiDi>697504445SVFORCEPQU</basicUdiDi>
    <tradeName>Toothed Forceps</tradeName>
    <deviceName>Disposable Ophthalmic Forceps</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>Q021102</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-S105-T1H1P（SF-11141-2）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:14.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044450002</udiDi>
    <basicUdiDi>697504445FORCEPPQ</basicUdiDi>
    <tradeName>Toothed Forceps</tradeName>
    <deviceName>Disposable Ophthalmic Forceps</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>Q021102</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F-S85-T1H1P（SF-11111-2）</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:10.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974957361290</udiDi>
    <basicUdiDi>697495736ED002KB</basicUdiDi>
    <tradeName>OPHTHALMIC SCISSORS(Microsurgical Scissors)</tradeName>
    <deviceName>OPHTHALMIC SCISSORS</deviceName>
    <manufacturerName>GAUSH PRECISION LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000028969</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021103</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-CP004001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:26.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974957361238</udiDi>
    <basicUdiDi>697495736ED006KK</basicUdiDi>
    <tradeName>IRRIGATION/ ASPIRATION INSTRUMENTS(Irrigating/ aspirating cannula)</tradeName>
    <deviceName>IRRIGATION/ ASPIRATION INSTRUMENTS</deviceName>
    <manufacturerName>GAUSH PRECISION LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000028969</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-CP007070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:25.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974957360873</udiDi>
    <basicUdiDi>697495736ED003KD</basicUdiDi>
    <tradeName>OPHTHALMIC HOOK(Strabismus hook)</tradeName>
    <deviceName>OPHTHALMIC HOOK</deviceName>
    <manufacturerName>GAUSH PRECISION LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000028969</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021110</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY SPOONS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-CP007080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:24.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974957360781</udiDi>
    <basicUdiDi>697495736ED007KM</basicUdiDi>
    <tradeName>POLISHING CURETTE(MODEL: capsule polishing curette)</tradeName>
    <deviceName>Polishing Curette</deviceName>
    <manufacturerName>GAUSH PRECISION LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000028969</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021109</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY SPATULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-CP002008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:20.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974957360019</udiDi>
    <basicUdiDi>697495736ED001K9</basicUdiDi>
    <tradeName>OPHTHALMIC FORCEPS(model: Meibomian glands dredging forceps)</tradeName>
    <deviceName>OPHTHALMIC FORCEPS</deviceName>
    <manufacturerName>GAUSH PRECISION LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000028969</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021102</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-CP202001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:19.258Z</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>15056030401302</udiDi>
    <basicUdiDi>50560304F11-FXQ</basicUdiDi>
    <tradeName>15056030401302</tradeName>
    <deviceName>Vitreoretinal Cannulae.</deviceName>
    <manufacturerName>Sterimedix Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011604</manufacturerSrn>
    <authorisedRepresentativeName>Bausch &amp; Lomb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006810</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4477-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:39.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056030401272</udiDi>
    <basicUdiDi>50560304F11-BXG</basicUdiDi>
    <tradeName>15056030401272</tradeName>
    <deviceName>Vitreoretinal Cannulae (F11-B)</deviceName>
    <manufacturerName>Sterimedix Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011604</manufacturerSrn>
    <authorisedRepresentativeName>Bausch &amp; Lomb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006810</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4474NS-02/Y</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:39.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>35056030401276</udiDi>
    <basicUdiDi>50560304F11-DXL</basicUdiDi>
    <tradeName>35056030401276</tradeName>
    <deviceName>Sterile Heavy Liquid Infusion Cannulae.</deviceName>
    <manufacturerName>Sterimedix Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011604</manufacturerSrn>
    <authorisedRepresentativeName>Bausch &amp; Lomb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006810</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M4474-02/10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:38.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056030403023</udiDi>
    <basicUdiDi>50560304F12-IY3</basicUdiDi>
    <tradeName>15056030403023</tradeName>
    <deviceName>Active/Passive backflush handle with soft-tip cannula.</deviceName>
    <manufacturerName>Sterimedix Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011604</manufacturerSrn>
    <authorisedRepresentativeName>Bausch &amp; Lomb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006810</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M4504-02/5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:37.494Z</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>
</eudamedExport>