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    <tradeName>SYRINGE</tradeName>
    <deviceName>ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI02.5L/L-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:21:53.307Z</lastUpdated>
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    <udiDi>08033860017446</udiDi>
    <basicUdiDi>8033860KYPFT05A1S3Z</basicUdiDi>
    <tradeName>SYRINGE</tradeName>
    <deviceName>ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIW03MED-D4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:11:11.086Z</lastUpdated>
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    <udiDi>08033860016715</udiDi>
    <basicUdiDi>8033860SFFT01CU2</basicUdiDi>
    <tradeName>ZEMENTKANÜLE</tradeName>
    <deviceName>CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-SF0927</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:11:08.688Z</lastUpdated>
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    <udiDi>06923558506203</udiDi>
    <basicUdiDi>69235585KT07CE01U7</basicUdiDi>
    <tradeName>06923558506203</tradeName>
    <deviceName>Kyphoplasty Tool Kit</deviceName>
    <manufacturerName>Jiangsu Changmei Medtech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012609</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-00-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:55.350Z</lastUpdated>
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  <row>
    <udiDi>05904151403107</udiDi>
    <basicUdiDi>59041514GS01JX</basicUdiDi>
    <tradeName>Łopatka do gipsu typu LICHTENSTEIN, dł. 160 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000052302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO 201</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:26:16.313Z</lastUpdated>
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  <row>
    <udiDi>05060238201377</udiDi>
    <basicUdiDi>50602382010A5F</basicUdiDi>
    <tradeName>SmartMix™ Syringe Gun</tradeName>
    <deviceName>Bone Cement Delivery Gun</deviceName>
    <manufacturerName>Summit Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5401-76-513</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:35:09.331Z</lastUpdated>
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  <row>
    <udiDi>04250203921466</udiDi>
    <basicUdiDi>425020392011000ZP</basicUdiDi>
    <tradeName>04250203921466</tradeName>
    <deviceName>Mixer</deviceName>
    <manufacturerName>Joline GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:54:32.591Z</lastUpdated>
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  <row>
    <udiDi>08033860047191</udiDi>
    <basicUdiDi>8033860SFFT01CU2</basicUdiDi>
    <tradeName>SCREWFIX</tradeName>
    <deviceName>CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR216SU</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:50:03.473Z</lastUpdated>
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  <row>
    <udiDi>08033860032203</udiDi>
    <basicUdiDi>8033860KYPFT05A1S3Z</basicUdiDi>
    <tradeName>RTI-SIR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTI-SI025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:49:18.775Z</lastUpdated>
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  <row>
    <udiDi>08033860033996</udiDi>
    <basicUdiDi>8033860KYPFT05A1S3Z</basicUdiDi>
    <tradeName>ADITUS SYRINGE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKSI25-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:49:16.626Z</lastUpdated>
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  <row>
    <udiDi>08033860035716</udiDi>
    <basicUdiDi>8033860KYPFT05A1S3Z</basicUdiDi>
    <tradeName>SANZA CEMENT MIXING SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIS-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:49:14.614Z</lastUpdated>
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  <row>
    <udiDi>08033860040628</udiDi>
    <basicUdiDi>8033860KYPFT05A1S3Z</basicUdiDi>
    <tradeName>VERTESTABLE SYRINGE WITH LUER-LOCK CONNECTION 2.5 ML (1 UNIT/POUCH)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>458070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:48:56.658Z</lastUpdated>
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  <row>
    <udiDi>05060238201810</udiDi>
    <basicUdiDi>50602382010A5F</basicUdiDi>
    <tradeName>Bone Cement Delivery Gun</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H759</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:28:03.773Z</lastUpdated>
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  <row>
    <udiDi>05060238201827</udiDi>
    <basicUdiDi>50602382010A5F</basicUdiDi>
    <tradeName>Bone Cement Delivery Gun</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H759L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:28:03.748Z</lastUpdated>
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    <udiDi>05060238201834</udiDi>
    <basicUdiDi>50602382010A5F</basicUdiDi>
    <tradeName>MultiMix™ Bone Cement Delivery Gun</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H749F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:28:03.728Z</lastUpdated>
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    <udiDi>05060238201841</udiDi>
    <basicUdiDi>50602382010A5F</basicUdiDi>
    <tradeName>Bone Cement Delivery Gun</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Summit Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000019193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H719</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:28:03.680Z</lastUpdated>
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    <udiDi>D-007B(II)/SVD3.4*1903P</udiDi>
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    <tradeName>FWS-007B(II) Solid Vertebral Drill ϕ3.4×190</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:27:01.760Z</lastUpdated>
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    <udiDi>08058964724618</udiDi>
    <basicUdiDi>805896472kit3W</basicUdiDi>
    <tradeName>V-MIX 02</tradeName>
    <deviceName>V-MIX</deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800046</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:10:02.523Z</lastUpdated>
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    <udiDi>04260102131231</udiDi>
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    <tradeName>PALAMIX vacuum pump</tradeName>
    <deviceName>PALAMIX vacuum pump</deviceName>
    <manufacturerName>Heraeus Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008199</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66036748</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:15:44.091Z</lastUpdated>
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    <udiDi>04260102131170</udiDi>
    <basicUdiDi>42601021304060001KD</basicUdiDi>
    <tradeName>PALAMIX cement gun</tradeName>
    <deviceName>PALAMIX cement gun</deviceName>
    <manufacturerName>Heraeus Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008199</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66036163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:15:43.298Z</lastUpdated>
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