<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04546951618674</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 020 04/025 04/025 06(25㎜)</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618681</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 020 04/025 04/025 06(28㎜)</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618698</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 020 04/025 04/025 06(31㎜)</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618704</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 025 14 18mm/013 04 020 04 21mm</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618711</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 025 14 18mm/013 04 020 04 25mm</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618728</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 025 14 18mm/013 04 020 04 28mm</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618735</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 025 14 18mm/013 04 020 04 31mm</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618742</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 020 04 21mm</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618759</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 020 04 25mm</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618766</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 020 04 28mm</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951618773</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 020 04 31mm</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951619091</udiDi>
    <basicUdiDi>4546951000023ZK</basicUdiDi>
    <tradeName>MANI MICRO FORCEPS - Square Type 25G</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 SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSQ25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951619107</udiDi>
    <basicUdiDi>4546951000023ZK</basicUdiDi>
    <tradeName>MANI MICRO FORCEPS - Round Type 25G</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 SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRD25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633134</udiDi>
    <basicUdiDi>4546951000004ZF</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 2-0 SILK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010202020301</emdnCode>
    <emdnDescription>SILK WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633158</udiDi>
    <basicUdiDi>4546951000006ZK</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 3-0 NYLON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633165</udiDi>
    <basicUdiDi>4546951000004ZF</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 4-0 SILK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010202020301</emdnCode>
    <emdnDescription>SILK WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633172</udiDi>
    <basicUdiDi>4546951000006ZK</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 4-0 NYLON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633189</udiDi>
    <basicUdiDi>4546951000006ZK</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 3-0 NYLON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633196</udiDi>
    <basicUdiDi>4546951000004ZF</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 4-0 SILK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010202020301</emdnCode>
    <emdnDescription>SILK WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633202</udiDi>
    <basicUdiDi>4546951000006ZK</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 4-0 NYLON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T13:04:55.301Z</lastUpdated>
  </row>
</eudamedExport>