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<eudamedExport entity="devices">
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    <udiDi>04546951605933</udiDi>
    <basicUdiDi>B-04546951605933</basicUdiDi>
    <tradeName>JIZAI - 025 14 31mm</tradeName>
    <deviceName>MANI NiTi 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>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:25.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951601515</udiDi>
    <basicUdiDi>B-04546951601515</basicUdiDi>
    <tradeName>MANI CARBIDE BURS - 7(CA)</tradeName>
    <deviceName>MANI CARBIDE BURS</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>MDD</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:20.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951500160</udiDi>
    <basicUdiDi>B-04546951500160</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 3-0 SILK</tradeName>
    <deviceName>MANI SUTURES SILK</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>MDD</legislation>
    <emdnCode>H010202020301</emdnCode>
    <emdnDescription>SILK WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:20.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951404321</udiDi>
    <basicUdiDi>B-04546951404321</basicUdiDi>
    <tradeName>MANI SUTURES POLYPROPYLENE - 7-0 POLYPROPYLENE</tradeName>
    <deviceName>MANI SUTURES POLYPROPYLENE</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>MDD</legislation>
    <emdnCode>H010201010401</emdnCode>
    <emdnDescription>POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3309</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:19.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951403492</udiDi>
    <basicUdiDi>B-04546951403492</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - MVR-Angled 23G-D</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>MDD</legislation>
    <emdnCode>Q02010102</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, ANGLED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVR23AD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:18.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951402228</udiDi>
    <basicUdiDi>B-04546951402228</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 9-0 SILK</tradeName>
    <deviceName>MANI SUTURES SILK</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>MDD</legislation>
    <emdnCode>H010202020301</emdnCode>
    <emdnDescription>SILK WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:14.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951401245</udiDi>
    <basicUdiDi>B-04546951401245</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 11-0 NYLON</tradeName>
    <deviceName>MANI SUTURES NYLON</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>MDD</legislation>
    <emdnCode>H010201010101</emdnCode>
    <emdnDescription>POLYAMIDE MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1403</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:13.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400224</udiDi>
    <basicUdiDi>B-04546951400224</basicUdiDi>
    <tradeName>MANI OPHTHALMIC KNIFE - MVR-Lance 20G</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>MDD</legislation>
    <emdnCode>Q02010101</emdnCode>
    <emdnDescription>OPHTHALMIC MICROKNIVES, STRAIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVR20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:12.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633752</udiDi>
    <basicUdiDi>4546951000005ZH</basicUdiDi>
    <tradeName>MANI SUTURES POLYPROPYLENE - 10-0 POLYPROPYLENE</tradeName>
    <deviceName>MANI SUTURES POLYPROPYLENE</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>H010201010401</emdnCode>
    <emdnDescription>POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1415</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:07.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633141</udiDi>
    <basicUdiDi>4546951000006ZK</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 4-0 NYLON</tradeName>
    <deviceName>MANI SUTURES NYLON</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>12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:05.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633127</udiDi>
    <basicUdiDi>4546951000004ZF</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 3-0 SILK</tradeName>
    <deviceName>MANI SUTURES SILK</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>10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:04.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951633486</udiDi>
    <basicUdiDi>4546951000007ZM</basicUdiDi>
    <tradeName>MANI SUTURES POLYESTER - 5-0 POLYESTER</tradeName>
    <deviceName>MANI SUTURES POLYESTER</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>H010201020201</emdnCode>
    <emdnDescription>POLYSTER MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:03.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951617066</udiDi>
    <basicUdiDi>4546951000024ZM</basicUdiDi>
    <tradeName>JIZAI - 013 04 21mm</tradeName>
    <deviceName>MANI NiTi FILES R</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>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:00.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951616502</udiDi>
    <basicUdiDi>4546951000010ZA</basicUdiDi>
    <tradeName>Manipler AZ 35W Disposable Skin Stapler - 783100</tradeName>
    <deviceName>ManiplerAZ</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>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>783100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:59.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951616427</udiDi>
    <basicUdiDi>4546951000023ZK</basicUdiDi>
    <tradeName>MANI MICRO FORCEPS - Square Type 27G</tradeName>
    <deviceName>MANI MICRO FORCEPS</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 SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSQ27</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:58.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951606220</udiDi>
    <basicUdiDi>4546951000018ZS</basicUdiDi>
    <tradeName>MANI DIA-BURS - WR-S31F</tradeName>
    <deviceName>MANI DIA-BURS</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>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:57.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951605698</udiDi>
    <basicUdiDi>4546951000015ZL</basicUdiDi>
    <tradeName>JIZAI - 045 04 21mm</tradeName>
    <deviceName>MANI NiTi 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>2026-07-01T20:45:56.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951525620</udiDi>
    <basicUdiDi>4546951000017ZQ</basicUdiDi>
    <tradeName>MANI SURGICAL BURS - 25MM MZB+</tradeName>
    <deviceName>MANI CARBIDE BURS</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>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:56.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951521103</udiDi>
    <basicUdiDi>4546951000002ZB</basicUdiDi>
    <tradeName>MANI SHORT BARBED BAORCHES - 21mm #1</tradeName>
    <deviceName>MANI SHORT BARBED BROACHES</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:55.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951518134</udiDi>
    <basicUdiDi>4546951000019ZU</basicUdiDi>
    <tradeName>MANI MI STAINLESS BURS - 22mm #2</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>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:54.523Z</lastUpdated>
  </row>
</eudamedExport>