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    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-08-04T00:51:29.800Z</lastUpdated>
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    <udiDi>08033860037314</udiDi>
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    <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>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>08033860035518</udiDi>
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    <tradeName>KYPHOSET DRILL</tradeName>
    <deviceName>KYPHOSET DRILL</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-08-04T00:50:47.290Z</lastUpdated>
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    <udiDi>08033860035501</udiDi>
    <basicUdiDi>B-08033860035501</basicUdiDi>
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    <deviceName>KYPHOSET WORKING CANNULA AND BEVEL TIP</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11KSBEVEL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:50:46.535Z</lastUpdated>
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    <udiDi>08033860035471</udiDi>
    <basicUdiDi>B-08033860035471</basicUdiDi>
    <tradeName>KYPHOKIT BALLOON CATHETER</tradeName>
    <deviceName>KYPHOKIT 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>KBAL15MC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:50:45.745Z</lastUpdated>
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    <udiDi>08033860035402</udiDi>
    <basicUdiDi>B-08033860035402</basicUdiDi>
    <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>KK13-DRI</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:50:40.955Z</lastUpdated>
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    <udiDi>08033860035396</udiDi>
    <basicUdiDi>B-08033860035396</basicUdiDi>
    <tradeName>KYPHOKIT WORKING CANNULA AND BEVEL TIP</tradeName>
    <deviceName>KYPHOKIT WORKING CANNULA AND BEVEL TIP</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
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    <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>KK13-WB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:50:40.157Z</lastUpdated>
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    <udiDi>08033860034771</udiDi>
    <basicUdiDi>B-08033860034771</basicUdiDi>
    <tradeName>RENOVA SPINE KYPHOPLASTY DRILL</tradeName>
    <deviceName>RENOVA SPINE KYPHOPLASTY 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>RESDRI1112C-US</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:50:28.895Z</lastUpdated>
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    <udiDi>08033860034764</udiDi>
    <basicUdiDi>B-08033860034764</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>RESWTR1112C-US</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:50:28.076Z</lastUpdated>
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    <udiDi>08033860034757</udiDi>
    <basicUdiDi>B-08033860034757</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>RESWB1112C-US</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:50:27.281Z</lastUpdated>
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    <udiDi>08033860032500</udiDi>
    <basicUdiDi>B-08033860032500</basicUdiDi>
    <tradeName>RTI-K</tradeName>
    <deviceName>RTI-K</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>RTI-KG11B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:49:20.005Z</lastUpdated>
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    <udiDi>08033860032494</udiDi>
    <basicUdiDi>B-08033860032494</basicUdiDi>
    <tradeName>RTI-K</tradeName>
    <deviceName>RTI-K</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>RTI-KG11DR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:49:19.164Z</lastUpdated>
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    <udiDi>08033860032487</udiDi>
    <basicUdiDi>B-08033860032487</basicUdiDi>
    <tradeName>RTI-K</tradeName>
    <deviceName>RTI-K</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>RTI-KG11T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:49:00.720Z</lastUpdated>
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    <udiDi>08033860031794</udiDi>
    <basicUdiDi>B-08033860031794</basicUdiDi>
    <tradeName>RTI-K</tradeName>
    <deviceName>RTI-K</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTI-K112</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:48:35.086Z</lastUpdated>
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    <udiDi>08033860031787</udiDi>
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    <tradeName>RTI-K</tradeName>
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    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTI-K111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:48:34.313Z</lastUpdated>
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    <udiDi>08033860031763</udiDi>
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    <tradeName>RTI-K</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTI-KB20J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:48:33.488Z</lastUpdated>
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    <tradeName>RTI-K</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTI-KB15J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:48:32.685Z</lastUpdated>
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    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTI-KB10J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:48:28.701Z</lastUpdated>
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    <udiDi>08033860029982</udiDi>
    <basicUdiDi>B-08033860029982</basicUdiDi>
    <tradeName>KYPHOKIT WORKING CANNULA AND BEVEL TIP</tradeName>
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    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK11-WB-AMS</reference>
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    <lastUpdated>2026-08-04T00:46:32.512Z</lastUpdated>
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    <tradeName>KYPHOKIT WORKING CANNULA AND TROCAR TIP</tradeName>
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    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK11-WTR-AMS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:45:32.381Z</lastUpdated>
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