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    <basicUdiDi>B-04546951400576</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 5-0 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>3854</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:47.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400569</udiDi>
    <basicUdiDi>B-04546951400569</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 5-0 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>3854S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:46.929Z</lastUpdated>
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  <row>
    <udiDi>04546951400552</udiDi>
    <basicUdiDi>B-04546951400552</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 5-0 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>3855</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:46.127Z</lastUpdated>
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    <udiDi>04546951400545</udiDi>
    <basicUdiDi>B-04546951400545</basicUdiDi>
    <tradeName>MANI SUTURES SILK - 5-0 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>3855S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:42.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400538</udiDi>
    <basicUdiDi>B-04546951400538</basicUdiDi>
    <tradeName>MANI SUTURES POLYESTER - 4-0 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>MDD</legislation>
    <emdnCode>H010201020201</emdnCode>
    <emdnDescription>POLYSTER MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4357</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:41.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400514</udiDi>
    <basicUdiDi>B-04546951400514</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>MDD</legislation>
    <emdnCode>H010201010401</emdnCode>
    <emdnDescription>POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1486L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:40.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400507</udiDi>
    <basicUdiDi>B-04546951400507</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 6-0 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>3382</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:39.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951400484</udiDi>
    <basicUdiDi>B-04546951400484</basicUdiDi>
    <tradeName>MANI SUTURES NYLON - 10-0 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>1459S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:29:35.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951362447</udiDi>
    <basicUdiDi>B-04546951362447</basicUdiDi>
    <tradeName>Manipler DSX 35W Disposable Skin Stapler - DS35WS</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>MDD</legislation>
    <emdnCode>H02010101</emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS35WS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:28:38.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951362102</udiDi>
    <basicUdiDi>B-04546951362102</basicUdiDi>
    <tradeName>Manipler AZ 35W Disposable Skin Stapler - AZ35WS</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>MDD</legislation>
    <emdnCode>H02010101</emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AZ35WS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:28:38.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951356224</udiDi>
    <basicUdiDi>B-04546951356224</basicUdiDi>
    <tradeName>Manipler S-2 35W Disposable Skin Stapler - S235W</tradeName>
    <deviceName>Manipler</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>H02010101</emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S235W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:28:36.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>04544607401540</udiDi>
    <basicUdiDi>B-04544607401540</basicUdiDi>
    <tradeName>04544607401540</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKL-2-120C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:43.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>04544607401533</udiDi>
    <basicUdiDi>B-04544607401533</basicUdiDi>
    <tradeName>04544607401533</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKL-2-60C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:41.955Z</lastUpdated>
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  <row>
    <udiDi>04544607401526</udiDi>
    <basicUdiDi>B-04544607401526</basicUdiDi>
    <tradeName>04544607401526</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKL-1-120C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:41.177Z</lastUpdated>
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  <row>
    <udiDi>04544607401519</udiDi>
    <basicUdiDi>B-04544607401519</basicUdiDi>
    <tradeName>04544607401519</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKL-1-60C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:39.557Z</lastUpdated>
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    <udiDi>04544607401502</udiDi>
    <basicUdiDi>B-04544607401502</basicUdiDi>
    <tradeName>04544607401502</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKM-2-60C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:37.160Z</lastUpdated>
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    <udiDi>04544607401496</udiDi>
    <basicUdiDi>B-04544607401496</basicUdiDi>
    <tradeName>04544607401496</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKM-2-30C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:35.573Z</lastUpdated>
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    <udiDi>04544607401489</udiDi>
    <basicUdiDi>B-04544607401489</basicUdiDi>
    <tradeName>04544607401489</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKM-1-60C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:34.764Z</lastUpdated>
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    <udiDi>04544607401472</udiDi>
    <basicUdiDi>B-04544607401472</basicUdiDi>
    <tradeName>04544607401472</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKM-1-30C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:33.164Z</lastUpdated>
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    <udiDi>04544607401441</udiDi>
    <basicUdiDi>B-04544607401441</basicUdiDi>
    <tradeName>04544607401441</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BEAR Medic Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000018095</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H0399</emdnCode>
    <emdnDescription>HAEMOSTASIS CLIPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TKS-1-40C</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:30.936Z</lastUpdated>
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</eudamedExport>