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<eudamedExport entity="devices">
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    <tradeName>KYPHOKIT DRILL</tradeName>
    <deviceName>KYPHOKIT DRILL</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK11-DRI-AMS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:45:25.294Z</lastUpdated>
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    <udiDi>08033860027896</udiDi>
    <basicUdiDi>B-08033860027896</basicUdiDi>
    <tradeName>KYPHOKIT FAST ACCESS SYSTEM</tradeName>
    <deviceName>KYPHOKIT FAST ACCESS SYSTEM</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK11-002V-AMS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:45:24.409Z</lastUpdated>
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    <udiDi>08033860027186</udiDi>
    <basicUdiDi>B-08033860027186</basicUdiDi>
    <tradeName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP</tradeName>
    <deviceName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESWTR1212C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:45:12.405Z</lastUpdated>
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    <udiDi>08033860026547</udiDi>
    <basicUdiDi>B-08033860026547</basicUdiDi>
    <tradeName>RENOVA SPINE FAST ACCESS SYSTEM</tradeName>
    <deviceName>RENOVA SPINE FAST ACCESS SYSTEM</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESTR1112002V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:44:28.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860026516</udiDi>
    <basicUdiDi>B-08033860026516</basicUdiDi>
    <tradeName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP</tradeName>
    <deviceName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESWB1212C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:44:27.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860024840</udiDi>
    <basicUdiDi>B-08033860024840</basicUdiDi>
    <tradeName>RENOVA SPINE FAST ACCESS SYSTEM</tradeName>
    <deviceName>RENOVA SPINE FAST ACCESS SYSTEM</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESTR1112001V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:41:33.423Z</lastUpdated>
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  <row>
    <udiDi>08033860024536</udiDi>
    <basicUdiDi>B-08033860024536</basicUdiDi>
    <tradeName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP</tradeName>
    <deviceName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESWBTR1112CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:41:22.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860019280</udiDi>
    <basicUdiDi>B-08033860019280</basicUdiDi>
    <tradeName>RENOVA SPINE FAST ACCESS SYSTEM</tradeName>
    <deviceName>RENOVA SPINE FAST ACCESS SYSTEM</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RES1212002V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:38:15.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860019242</udiDi>
    <basicUdiDi>B-08033860019242</basicUdiDi>
    <tradeName>RENOVA SPINE FAST ACCESS SYSTEM</tradeName>
    <deviceName>RENOVA SPINE FAST ACCESS SYSTEM</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RES1212001V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:37:57.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860019068</udiDi>
    <basicUdiDi>B-08033860019068</basicUdiDi>
    <tradeName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP</tradeName>
    <deviceName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESWD0812C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:37:53.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860018955</udiDi>
    <basicUdiDi>B-08033860018955</basicUdiDi>
    <tradeName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPANDER</tradeName>
    <deviceName>RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPANDER</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESWT1112C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:37:53.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860018801</udiDi>
    <basicUdiDi>B-08033860018801</basicUdiDi>
    <tradeName>RENOVA SPINE CLASSIC ACCESS SYSTEM</tradeName>
    <deviceName>RENOVA SPINE CLASSIC ACCESS SYSTEM</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RES1112001L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:37:48.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860018788</udiDi>
    <basicUdiDi>B-08033860018788</basicUdiDi>
    <tradeName>RENOVA SPINE CLASSIC ACCESS SYSTEM</tradeName>
    <deviceName>RENOVA SPINE CLASSIC ACCESS SYSTEM</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RES1112002L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:37:46.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860017965</udiDi>
    <basicUdiDi>B-08033860017965</basicUdiDi>
    <tradeName>RENOVA SPINE BALLOON CATHETER</tradeName>
    <deviceName>RENOVA SPINE BALLOON CATHETER</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESB15VM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:36:56.227Z</lastUpdated>
  </row>
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    <udiDi>08033860017804</udiDi>
    <basicUdiDi>B-08033860017804</basicUdiDi>
    <tradeName>RENOVA SPINE BALLOON CATHETER</tradeName>
    <deviceName>RENOVA SPINE BALLOON CATHETER [EN]</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESB20VM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:36:49.906Z</lastUpdated>
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    <udiDi>08033860017545</udiDi>
    <basicUdiDi>B-08033860017545</basicUdiDi>
    <tradeName>RENOVA SPINE BALLOON CATHETER</tradeName>
    <deviceName>RENOVA SPINE BALLOON CATHETER</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESB10VM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:36:42.607Z</lastUpdated>
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    <udiDi>08033860016517</udiDi>
    <basicUdiDi>B-08033860016517</basicUdiDi>
    <tradeName>RENOVA SPINE KYPHOPLASTY BONE ACCESS NEEDLE</tradeName>
    <deviceName>RENOVA SPINE KYPHOPLASTY BONE ACCESS NEEDLE</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESOB0815TC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:36:27.378Z</lastUpdated>
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    <udiDi>06941201384152</udiDi>
    <basicUdiDi>B-06941201384152</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Bone Cement Mixer and Pusher</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>S71752500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:46:25.812Z</lastUpdated>
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    <udiDi>06941201304853</udiDi>
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    <tradeName>Carlon</tradeName>
    <deviceName>Bone Cement Injection</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>S71752600</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:46:21.015Z</lastUpdated>
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    <udiDi>06941201304846</udiDi>
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    <tradeName>Carlon</tradeName>
    <deviceName>Bone Cement Injection</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>S71752530</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:46:20.063Z</lastUpdated>
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