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    <tradeName>RENOVA SPINE FAST ACCESS SYSTEM</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RES1112001VB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:16.122Z</lastUpdated>
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    <udiDi>08033860024222</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE BONE FILLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>K010301</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESFIL1112C4B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:16.050Z</lastUpdated>
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    <udiDi>08033860024260</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE BONE FILLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>K010301</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESFIL1112C6B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:15.850Z</lastUpdated>
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    <udiDi>08033860024550</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE 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>RESFIL1114C1DTB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:17:50.863Z</lastUpdated>
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    <udiDi>08033860025656</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT BALLOON CATHETER</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>KBAL20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:17:48.315Z</lastUpdated>
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    <udiDi>08033860025915</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT BONE ACCESS NEEDLE</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>KK11-OB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:17:47.863Z</lastUpdated>
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  <row>
    <udiDi>08033860025922</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT KIRSCHNER GUIDE</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>KK11-FGP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:17:47.829Z</lastUpdated>
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  <row>
    <udiDi>08033860025946</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT WORKING CANNULA AND EXPANDER</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>KK08-WT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:17:47.776Z</lastUpdated>
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    <udiDi>08033860027322</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE FAST ACCESS SYSTEM</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>RES1112001V-V4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:17:46.371Z</lastUpdated>
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    <udiDi>08033860027339</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE FAST ACCESS SYSTEM</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>RES1112002V-V4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:17:46.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964726773</udiDi>
    <basicUdiDi>B-08058964726773</basicUdiDi>
    <tradeName>Winch Kyphoplasty Balloon Catheter 11G 20mm</tradeName>
    <deviceName>Winch Kyphoplasty Balloon Catheter 11G 20mm</deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030085</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>900028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:27:56.780Z</lastUpdated>
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    <udiDi>08058964726766</udiDi>
    <basicUdiDi>B-08058964726766</basicUdiDi>
    <tradeName>Winch Kyphoplasty Balloon Catheter 11G 15mm</tradeName>
    <deviceName>Winch Kyphoplasty Balloon Catheter 11G 15mm</deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030085</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>900027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:27:55.961Z</lastUpdated>
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  <row>
    <udiDi>08033860024277</udiDi>
    <basicUdiDi>B-08033860024277</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>RES1112002VB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:39:01.527Z</lastUpdated>
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  <row>
    <udiDi>07611819525382</udiDi>
    <basicUdiDi>7611819a00286JW</basicUdiDi>
    <tradeName>07611819525382</tradeName>
    <deviceName>Synflate Vertebral Balloon Small Medium Large</deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</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>03.804.700S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:42:39.200Z</lastUpdated>
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    <udiDi>07613327638240</udiDi>
    <basicUdiDi>08858251004429TC</basicUdiDi>
    <tradeName>Omnicurve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Stryker Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000025219</manufacturerSrn>
    <authorisedRepresentativeName>Stryker European Operations Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000092</authorisedRepresentativeSrn>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1032-020-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:29.539Z</lastUpdated>
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    <udiDi>07613327554649</udiDi>
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    <tradeName>Omnicurve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Stryker Instruments</manufacturerName>
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    <authorisedRepresentativeName>Stryker European Operations Limited</authorisedRepresentativeName>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1032-130-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:29.323Z</lastUpdated>
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    <udiDi>07613327554700</udiDi>
    <basicUdiDi>08858251004429TC</basicUdiDi>
    <tradeName>Omnicurve</tradeName>
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    <manufacturerName>Stryker Instruments</manufacturerName>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1033-120-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:28.984Z</lastUpdated>
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    <udiDi>07613327638431</udiDi>
    <basicUdiDi>08858251004429TC</basicUdiDi>
    <tradeName>Omnicurve</tradeName>
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    <authorisedRepresentativeName>Stryker European Operations Limited</authorisedRepresentativeName>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1033-020-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:28.967Z</lastUpdated>
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    <tradeName>Omnicurve</tradeName>
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    <manufacturerName>Stryker Instruments</manufacturerName>
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    <authorisedRepresentativeName>Stryker European Operations Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000092</authorisedRepresentativeSrn>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1033-130-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:28.953Z</lastUpdated>
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    <udiDi>07613327638226</udiDi>
    <basicUdiDi>08858251004429TC</basicUdiDi>
    <tradeName>Omnicurve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Stryker Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000025219</manufacturerSrn>
    <authorisedRepresentativeName>Stryker European Operations Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000092</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>1033-015-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:28.936Z</lastUpdated>
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