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    <basicUdiDi>B-08800038028838</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:54:29.632Z</lastUpdated>
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  <row>
    <udiDi>08809544174213</udiDi>
    <basicUdiDi>B-08809544174213</basicUdiDi>
    <tradeName>MEDINAUT Plus, SteriSpine VA</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-PIBE-40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:20:04.309Z</lastUpdated>
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  <row>
    <udiDi>08809317170435</udiDi>
    <basicUdiDi>B-08809317170435</basicUdiDi>
    <tradeName>MEDINUAT, B-Two Vertebral Balloon Expand System</tradeName>
    <deviceName>Vertebral Augmentation System</deviceName>
    <manufacturerName>IMEDICOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000002344</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-CAT-004-US-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:19:53.981Z</lastUpdated>
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    <udiDi>08033860025557</udiDi>
    <basicUdiDi>B-08033860025557</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>RESWTR0812C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-05T15:19:30.069Z</lastUpdated>
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  <row>
    <udiDi>06941201304150</udiDi>
    <basicUdiDi>B-06941201304150</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Expandor</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>S71750502</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:29:08.314Z</lastUpdated>
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  <row>
    <udiDi>06941201304143</udiDi>
    <basicUdiDi>B-06941201304143</basicUdiDi>
    <tradeName>Carlon</tradeName>
    <deviceName>Expandor</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>S71750501</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:29:06.705Z</lastUpdated>
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  <row>
    <udiDi>08033860046712</udiDi>
    <basicUdiDi>B-08033860046712</basicUdiDi>
    <tradeName>KYPHOSET BONE ACCESS NEEDLE</tradeName>
    <deviceName>KYPHOSET 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>11KSOB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:57:18.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860046699</udiDi>
    <basicUdiDi>B-08033860046699</basicUdiDi>
    <tradeName>KYPHOSET WORKING CANNULA AND EXPANDER</tradeName>
    <deviceName>KYPHOSET 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>08KSWC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:57:12.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860046675</udiDi>
    <basicUdiDi>B-08033860046675</basicUdiDi>
    <tradeName>KYPHOSET DRILL</tradeName>
    <deviceName>KYPHOSET 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>08KSDRILL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:56:59.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860046651</udiDi>
    <basicUdiDi>B-08033860046651</basicUdiDi>
    <tradeName>KYPHOSET KIRSCHNER GUIDE</tradeName>
    <deviceName>KYPHOSET KIRSCHNER GUIDE</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>11KSKGP</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:56:57.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860045791</udiDi>
    <basicUdiDi>B-08033860045791</basicUdiDi>
    <tradeName>KYPHOTRAY BALLOON CATHETER</tradeName>
    <deviceName>KYPHOTRAY 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>KTRB15J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:56:44.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860045784</udiDi>
    <basicUdiDi>B-08033860045784</basicUdiDi>
    <tradeName>KYPHOTRAY FAST ACCESS SYSTEM</tradeName>
    <deviceName>KYPHOTRAY 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>KTY11-002V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:56:43.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860044916</udiDi>
    <basicUdiDi>B-08033860044916</basicUdiDi>
    <tradeName>OSTEOPEARL</tradeName>
    <deviceName>OSTEOPEARL</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>100.434</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:56:24.078Z</lastUpdated>
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  <row>
    <udiDi>08033860044930</udiDi>
    <basicUdiDi>B-08033860044930</basicUdiDi>
    <tradeName>OSTEOPEARL</tradeName>
    <deviceName>OSTEOPEARL</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>100.436</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:56:23.289Z</lastUpdated>
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    <udiDi>08033860044893</udiDi>
    <basicUdiDi>B-08033860044893</basicUdiDi>
    <tradeName>OSTEOPEARL</tradeName>
    <deviceName>OSTEOPEARL</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>100.432</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:56:22.390Z</lastUpdated>
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    <udiDi>08033860043643</udiDi>
    <basicUdiDi>B-08033860043643</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>RESWB0812C-US</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:55:51.213Z</lastUpdated>
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    <udiDi>08033860040284</udiDi>
    <basicUdiDi>B-08033860040284</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>KBAL20MC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:54:51.674Z</lastUpdated>
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    <udiDi>08033860040260</udiDi>
    <basicUdiDi>B-08033860040260</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>KBAL10MC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:54:47.670Z</lastUpdated>
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    <udiDi>08033860038687</udiDi>
    <basicUdiDi>B-08033860038687</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>RESWBTR1312C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:52:18.510Z</lastUpdated>
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    <udiDi>08033860037512</udiDi>
    <basicUdiDi>B-08033860037512</basicUdiDi>
    <tradeName>VERTEMAX WORKING CANNULA AND BEVEL/TROCAR TIP</tradeName>
    <deviceName>VERTEMAX 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>VMX-08DA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:51:33.792Z</lastUpdated>
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