<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06941201304013</udiDi>
    <basicUdiDi>B-06941201304013</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750110</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:39.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201304006</udiDi>
    <basicUdiDi>B-06941201304006</basicUdiDi>
    <tradeName>Trocar</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750109</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:38.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303986</udiDi>
    <basicUdiDi>B-06941201303986</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750107</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:34.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303993</udiDi>
    <basicUdiDi>B-06941201303993</basicUdiDi>
    <tradeName>Trocar</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750108</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:34.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303979</udiDi>
    <basicUdiDi>B-06941201303979</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750106</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:33.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303962</udiDi>
    <basicUdiDi>B-06941201303962</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750105</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:32.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303955</udiDi>
    <basicUdiDi>B-06941201303955</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750104</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:29.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303948</udiDi>
    <basicUdiDi>B-06941201303948</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750103</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:27.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303931</udiDi>
    <basicUdiDi>B-06941201303931</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:26.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303924</udiDi>
    <basicUdiDi>B-06941201303924</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Trocar</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71750101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:26.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303856</udiDi>
    <basicUdiDi>B-06941201303856</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Balloon</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71712014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:22.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303849</udiDi>
    <basicUdiDi>B-06941201303849</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Balloon</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71712012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:21.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303832</udiDi>
    <basicUdiDi>B-06941201303832</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Balloon</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71711514</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:20.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303825</udiDi>
    <basicUdiDi>B-06941201303825</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Balloon</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71711512</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:19.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303818</udiDi>
    <basicUdiDi>B-06941201303818</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Balloon</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71711014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:15.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941201303801</udiDi>
    <basicUdiDi>B-06941201303801</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Balloon</deviceName>
    <manufacturerName>Jiangsu Trauhui Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039433</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S71711012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:41:14.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860010768</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE BALLOON CATHETER</tradeName>
    <deviceName>KYPHOPLASTY SYSTEMS</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESB15PM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:21:36.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860010751</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE BALLOON CATHETER</tradeName>
    <deviceName>KYPHOPLASTY SYSTEMS</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESB10PM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:11:10.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860027872</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT BONE FILLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK11-FIL6-AMS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:58:25.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860027889</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT BONE FILLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK15-FIL3-AMS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:58:25.817Z</lastUpdated>
  </row>
</eudamedExport>