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<eudamedExport entity="devices">
  <row>
    <udiDi>06974957361535</udiDi>
    <basicUdiDi>697495736ED005KH</basicUdiDi>
    <tradeName>DISPOSABLE SCALPEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GAUSH PRECISION LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000028969</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-CP201038</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:27.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974343990295</udiDi>
    <basicUdiDi>697434399003ML</basicUdiDi>
    <tradeName>06974343990295</tradeName>
    <deviceName>Disposable Sterile Ophthalmic Surgical Knives</deviceName>
    <manufacturerName>2nd Sight Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014431</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:55:46.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974343990288</udiDi>
    <basicUdiDi>697434399005MQ</basicUdiDi>
    <tradeName>06974343990288</tradeName>
    <deviceName>Disposable Sterile Ophthalmic Surgical Knives</deviceName>
    <manufacturerName>2nd Sight Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014431</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:55:42.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974343990219</udiDi>
    <basicUdiDi>697434399001MG</basicUdiDi>
    <tradeName>06974343990219</tradeName>
    <deviceName>Disposable Sterile Ophthalmic Surgical Knives</deviceName>
    <manufacturerName>2nd Sight Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014431</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:55:26.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974343990127</udiDi>
    <basicUdiDi>697434399006MS</basicUdiDi>
    <tradeName>06974343990127</tradeName>
    <deviceName>Disposable Sterile Ophthalmic Surgical Knives</deviceName>
    <manufacturerName>2nd Sight Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014431</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:55:25.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974343990042</udiDi>
    <basicUdiDi>697434399008MW</basicUdiDi>
    <tradeName>06974343990042</tradeName>
    <deviceName>Disposable Sterile Ophthalmic Surgical Knives</deviceName>
    <manufacturerName>2nd Sight Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014431</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:55:20.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974343990035</udiDi>
    <basicUdiDi>697434399002MJ</basicUdiDi>
    <tradeName>06974343990035</tradeName>
    <deviceName>Disposable Sterile Ophthalmic Surgical Knives</deviceName>
    <manufacturerName>2nd Sight Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014431</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:55:19.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974343990011</udiDi>
    <basicUdiDi>697434399004MN</basicUdiDi>
    <tradeName>06974343990011</tradeName>
    <deviceName>Disposable Sterile Ophthalmic Surgical Knives</deviceName>
    <manufacturerName>2nd Sight Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014431</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:55:17.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951604851</udiDi>
    <basicUdiDi>B-04546951604851</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Needling Knife 1.0mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MND10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:35:20.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951604080</udiDi>
    <basicUdiDi>B-04546951604080</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Universal Bevel Up 0.8mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MUN08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:35:19.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951601911</udiDi>
    <basicUdiDi>4546951000011ZC</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Double Step-Angled 1.0mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSL10DSK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:35:10.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951405823</udiDi>
    <basicUdiDi>B-04546951405823</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Slit-Angled 2.3mm Arched</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSL23AB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:37.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951405816</udiDi>
    <basicUdiDi>B-04546951405816</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Slit-Angled 2.9mm Arched</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSL29AB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:36.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951405724</udiDi>
    <basicUdiDi>B-04546951405724</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Side Port30°Angled 1.0mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSP10L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:29.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951405717</udiDi>
    <basicUdiDi>B-04546951405717</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Side Port45°Angled 1.0mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSP10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:28.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951404536</udiDi>
    <basicUdiDi>B-04546951404536</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Crescent Bevel Up 2.0mm SH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCU20SH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:21.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951404529</udiDi>
    <basicUdiDi>B-04546951404529</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Crescent Bevel Up 2.3mm SH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCU26SH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:20.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951404512</udiDi>
    <basicUdiDi>B-04546951404512</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Slit-Angled 3.0mm SH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSL30SH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:20.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951404505</udiDi>
    <basicUdiDi>B-04546951404505</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Slit-Angled 2.9mm SH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSL29SH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:19.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951404499</udiDi>
    <basicUdiDi>B-04546951404499</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Slit-Angled 2.8mm SH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSL28SH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T05:18:18.227Z</lastUpdated>
  </row>
</eudamedExport>