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    <udiDi>08682024000451</udiDi>
    <basicUdiDi>8682024KFP290324SU</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM BONE INTERVENTION KIT FIRST ENTRY NEEDLE</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFP290324</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:38.312Z</lastUpdated>
  </row>
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    <udiDi>08682024000444</udiDi>
    <basicUdiDi>8682024KFP290323SS</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM PRECISION SURGICAL DRILL</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFP290323</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:35.896Z</lastUpdated>
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    <udiDi>08682024000437</udiDi>
    <basicUdiDi>8682024KFP290322SQ</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM WORKING CANNULA</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFP290322</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:34.298Z</lastUpdated>
  </row>
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    <udiDi>08682024000420</udiDi>
    <basicUdiDi>8682024VTBK290321S6</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM VTB KIT -- VERTEBROPLASTY BONE INTERVENTION KIT FIRST ENTRY NEEDLE</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTBK290321</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:33.495Z</lastUpdated>
  </row>
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    <udiDi>08682024000413</udiDi>
    <basicUdiDi>8682024VTBK290320S4</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM VTB KIT -- VERTEBROPLASTY SPINE KIT</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTBK290320</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:31.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000352</udiDi>
    <basicUdiDi>8682024MIX180123Z7</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM Mix Cement Mixing Kit with Pressure- Vacuum</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIX180123</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:21.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000345</udiDi>
    <basicUdiDi>8682024MIX180122Z5</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM Mix Cement Mixing Kit with Pressure</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIX180122</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:20.697Z</lastUpdated>
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    <udiDi>08031497003771</udiDi>
    <basicUdiDi>80314970703P7</basicUdiDi>
    <tradeName>Mendec Kypho Set Bilateral 10 mm</tradeName>
    <deviceName>Mendec Kypho Set Bilateral</deviceName>
    <manufacturerName>Tecres S.p.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000027511</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASB028A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:44:11.015Z</lastUpdated>
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    <udiDi>08031497003658</udiDi>
    <basicUdiDi>80314970702P5</basicUdiDi>
    <tradeName>Mendec Kypho Set Monolateral 10 mm</tradeName>
    <deviceName>Mendec Kypho Set Monolateral</deviceName>
    <manufacturerName>Tecres S.p.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000027511</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASB026A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:44:10.217Z</lastUpdated>
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  <row>
    <udiDi>06939488524101</udiDi>
    <basicUdiDi>69394885000APS</basicUdiDi>
    <tradeName>Puncture Needle</tradeName>
    <deviceName>Vertebral Forming Unitized Surgical Instruments and Vertebroplasty Toolkit</deviceName>
    <manufacturerName>Dragon Crown Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032712</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LG08379</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:14.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938695581150</udiDi>
    <basicUdiDi>69386955HDKB</basicUdiDi>
    <tradeName>06938695581150</tradeName>
    <deviceName>Bone Cement Delivery System</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG8115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:48.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938695550026</udiDi>
    <basicUdiDi>69386955BAJK</basicUdiDi>
    <tradeName>Kyphoplasty Multifunctional Tool</tradeName>
    <deviceName>Kyphoplasty Multifunctional Tool</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG5100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:47.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938695542007</udiDi>
    <basicUdiDi>69386955LSLM</basicUdiDi>
    <tradeName>Locking Syringe</tradeName>
    <deviceName>Medical Balloon Catheter Syringe Pump</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG4200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:46.741Z</lastUpdated>
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    <udiDi>06938695540010</udiDi>
    <basicUdiDi>69386955SPM4</basicUdiDi>
    <tradeName>06938695540010</tradeName>
    <deviceName>Medical Balloon Catheter Syringe Pump</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG4001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:45.962Z</lastUpdated>
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    <udiDi>06938695537133</udiDi>
    <basicUdiDi>69386955FBJZ</basicUdiDi>
    <tradeName>06938695537133</tradeName>
    <deviceName>Balloon Catheter</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC102-2520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:45.143Z</lastUpdated>
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    <udiDi>06938695525000</udiDi>
    <basicUdiDi>69386955BFJV</basicUdiDi>
    <tradeName>06938695525000</tradeName>
    <deviceName>Bone Filler Device</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG2500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:44.341Z</lastUpdated>
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    <udiDi>06938695524003</udiDi>
    <basicUdiDi>69386955KT02ZU</basicUdiDi>
    <tradeName>06938695524003</tradeName>
    <deviceName>Dilator</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG2400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:43.546Z</lastUpdated>
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    <udiDi>06938695523037</udiDi>
    <basicUdiDi>69386955KT0423</basicUdiDi>
    <tradeName>06938695523037</tradeName>
    <deviceName>Guide Wire</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG2300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:42.753Z</lastUpdated>
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    <udiDi>06938695520180</udiDi>
    <basicUdiDi>69386955BXKZ</basicUdiDi>
    <tradeName>06938695520180</tradeName>
    <deviceName>Balloon Catheter</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FB2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:41.938Z</lastUpdated>
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    <udiDi>06938695520012</udiDi>
    <basicUdiDi>69386955KTIAP</basicUdiDi>
    <tradeName>Kyphoplasty Tool Kit</tradeName>
    <deviceName>Kyphoplasty Procedure Pack</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000040949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG2001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:41.271Z</lastUpdated>
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