<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04546951515485</udiDi>
    <basicUdiDi>4546951000014ZJ</basicUdiDi>
    <tradeName>MANI U-FILES - 27mm #10</tradeName>
    <deviceName>MANI U-FILES</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>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:53.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951513344</udiDi>
    <basicUdiDi>4546951000013ZG</basicUdiDi>
    <tradeName>MANI ENGINE REAMERS - 21mm #45</tradeName>
    <deviceName>Rotary SUS Files</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>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:52.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951512927</udiDi>
    <basicUdiDi>4546951000016ZN</basicUdiDi>
    <tradeName>MANI PEESO REAMERS - 28mm #1</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>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:52.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951505844</udiDi>
    <basicUdiDi>4546951000003ZD</basicUdiDi>
    <tradeName>MANI FLARE SPREADERS - 21mm #15</tradeName>
    <deviceName>MANI SPREADERS</deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159012</emdnCode>
    <emdnDescription>ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:51.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951500405</udiDi>
    <basicUdiDi>4546951000001Z9</basicUdiDi>
    <tradeName>MANI REAMERS - 18mm #15-40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:50.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951403997</udiDi>
    <basicUdiDi>4546951000022ZH</basicUdiDi>
    <tradeName>MANI INFUSION CANNULA - Infusion Cannula 25G S</tradeName>
    <deviceName>MANI TROCAR KIT</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>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIC25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:49.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951403973</udiDi>
    <basicUdiDi>4546951000021ZF</basicUdiDi>
    <tradeName>MANI TROCAR - Trocar 25G S</tradeName>
    <deviceName>MANI TROCAR KIT</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>MDR 2017/745</legislation>
    <emdnCode>Q020199</emdnCode>
    <emdnDescription>OPHTHALMIC CUTTING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTR25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:48.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951403959</udiDi>
    <basicUdiDi>4546951000012ZE</basicUdiDi>
    <tradeName>MANI TROCAR KIT - TROCAR KIT 25G S</tradeName>
    <deviceName>MANI TROCAR KIT</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>MDR 2017/745</legislation>
    <emdnCode>Q021113</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTK25S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:48.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400040</udiDi>
    <basicUdiDi>4546951000011ZC</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Straight 22.5°</tradeName>
    <deviceName>MANI OPHTHALMIC KNIFE</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, STRAIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MST22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:46.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951356224</udiDi>
    <basicUdiDi>B-04546951356224</basicUdiDi>
    <tradeName>Manipler S-2 35W Disposable Skin Stapler - S235W</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></emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S235W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951362102</udiDi>
    <basicUdiDi>B-04546951362102</basicUdiDi>
    <tradeName>Manipler AZ 35W Disposable Skin Stapler - AZ35WS</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></emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AZ35WS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951362447</udiDi>
    <basicUdiDi>B-04546951362447</basicUdiDi>
    <tradeName>Manipler DSX 35W Disposable Skin Stapler - DS35WS</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></emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS35WS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400019</udiDi>
    <basicUdiDi>B-04546951400019</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Straight 45°</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, STRAIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MST45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400026</udiDi>
    <basicUdiDi>B-04546951400026</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Straight 30°</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, STRAIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MST30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400057</udiDi>
    <basicUdiDi>B-04546951400057</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Straight 15°</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, STRAIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MST15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400064</udiDi>
    <basicUdiDi>B-04546951400064</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Crescent Bevel Down 2.3mm</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCD26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400071</udiDi>
    <basicUdiDi>B-04546951400071</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Crescent 2.3mm</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, STRAIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCS26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400088</udiDi>
    <basicUdiDi>B-04546951400088</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Crescent Bevel Up 2.3mm</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCU26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400095</udiDi>
    <basicUdiDi>B-04546951400095</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Slit-Angled 1.6mm</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSL16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400101</udiDi>
    <basicUdiDi>B-04546951400101</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - Slit 3.0mm</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></emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, STRAIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSS30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:12.537Z</lastUpdated>
  </row>
</eudamedExport>