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<eudamedExport entity="devices">
  <row>
    <udiDi>20844685000023</udiDi>
    <basicUdiDi>B-20844685000023</basicUdiDi>
    <tradeName>Malyugin Ring System</tradeName>
    <deviceName>Malyugin Ring System 6.25mm</deviceName>
    <manufacturerName>MicroSurgical Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020475</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:45:25.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130443</udiDi>
    <basicUdiDi>B-06976939130443</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Neonate 4mm bladed speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC15</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:13.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130436</udiDi>
    <basicUdiDi>B-06976939130436</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Paediatric 6mm bladed speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC14</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:11.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130429</udiDi>
    <basicUdiDi>B-06976939130429</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Kratz speculum open loop</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC13</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:09.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130412</udiDi>
    <basicUdiDi>B-06976939130412</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Temporal speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC12</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:07.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130405</udiDi>
    <basicUdiDi>B-06976939130405</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Kratz Barraquer open loop wire speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC11</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:07.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130399</udiDi>
    <basicUdiDi>B-06976939130399</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Kratz paediatric 10mm closed loop speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:05.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130382</udiDi>
    <basicUdiDi>B-06976939130382</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Kratz Barraquer wire closed loop speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC09</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:03.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130375</udiDi>
    <basicUdiDi>B-06976939130375</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Solid bladed adjustable speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC08</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:01.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130368</udiDi>
    <basicUdiDi>B-06976939130368</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Wide angled closed loop speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC07</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:00.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130344</udiDi>
    <basicUdiDi>B-06976939130344</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Kratz solid bladed speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC05</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:59.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130054</udiDi>
    <basicUdiDi>B-06976939130054</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Kratz screw adjustable open loop speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:34.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976939130047</udiDi>
    <basicUdiDi>B-06976939130047</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Bladed adjustable speculum</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:33.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404027442297</udiDi>
    <basicUdiDi>B-05404027442297</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName>555030NS: Non-Sterile, Single Use, Adjustable Speculum, Ginsberg Eye Speculum, 13mm Solid Blades, L 65mm</deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>555030NS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:31:20.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404027427423</udiDi>
    <basicUdiDi>B-05404027427423</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName>555026x10: Sterile, Single Use, Adjustable Speculum, Steinert Lasik Speculum, 14mm Inner Attached Round Solid Blades, L 65mm</deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>555026</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:30:48.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435194326988</udiDi>
    <basicUdiDi>84351943038SQ</basicUdiDi>
    <tradeName>CANABRAVA RING</tradeName>
    <deviceName>Anillo extensor de iris CANABRAVA RING</deviceName>
    <manufacturerName>AJL OPHTHALMIC, S.A</manufacturerName>
    <manufacturerSrn>ES-MF-000000267</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CANA-RING</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:44:53.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975044452006</udiDi>
    <basicUdiDi>697504445PUNCTALDILATORMU</basicUdiDi>
    <tradeName>Punctal Dilator</tradeName>
    <deviceName>Disposable Ophthalmic Punctal Dilator</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>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R11-S115-H3（SC-34015-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:35.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>24058935005249</udiDi>
    <basicUdiDi>4058935-070000-D7</basicUdiDi>
    <tradeName>Barraquer Lid Speculum</tradeName>
    <deviceName>Eye Speculum</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>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUH01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:39:11.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>24058935005263</udiDi>
    <basicUdiDi>4058935-070000-D7</basicUdiDi>
    <tradeName>Speculum adjustable</tradeName>
    <deviceName></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>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUH04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:13:45.749Z</lastUpdated>
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  <row>
    <udiDi>05404027427621</udiDi>
    <basicUdiDi>B-05404027427621</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021106</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>655042</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:34:26.316Z</lastUpdated>
  </row>
</eudamedExport>