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    <basicUdiDi>69386955KT0423</basicUdiDi>
    <tradeName>06938695523037</tradeName>
    <deviceName>Guide Wire</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG2300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:42.753Z</lastUpdated>
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    <udiDi>06938695520180</udiDi>
    <basicUdiDi>69386955BXKZ</basicUdiDi>
    <tradeName>06938695520180</tradeName>
    <deviceName>Balloon Catheter</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FB2015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:41.938Z</lastUpdated>
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    <udiDi>06938695520012</udiDi>
    <basicUdiDi>69386955KTIAP</basicUdiDi>
    <tradeName>Kyphoplasty Tool Kit</tradeName>
    <deviceName>Kyphoplasty Procedure Pack</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000040949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG2001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:41.271Z</lastUpdated>
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    <udiDi>06938695510808</udiDi>
    <basicUdiDi>69386955KPLC</basicUdiDi>
    <tradeName>06938695510808</tradeName>
    <deviceName>Puncture Needle</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG3003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:40.341Z</lastUpdated>
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    <udiDi>06938695510105</udiDi>
    <basicUdiDi>69386955BIK3</basicUdiDi>
    <tradeName>06938695510105</tradeName>
    <deviceName>Balloon Catheter</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG1001-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:39.550Z</lastUpdated>
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    <udiDi>06938695502254</udiDi>
    <basicUdiDi>69386955KT01ZS</basicUdiDi>
    <tradeName>06938695502254</tradeName>
    <deviceName>Cannula</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG2203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:38.752Z</lastUpdated>
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    <udiDi>06938695502230</udiDi>
    <basicUdiDi>69386955KT03ZW</basicUdiDi>
    <tradeName>06938695502230</tradeName>
    <deviceName>Drill</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG2102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:37.948Z</lastUpdated>
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    <udiDi>06938695502155</udiDi>
    <basicUdiDi>69386955BDJR</basicUdiDi>
    <tradeName>Bone Drill</tradeName>
    <deviceName>Bone Drill</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG2701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:37.143Z</lastUpdated>
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    <udiDi>06938695501301</udiDi>
    <basicUdiDi>69386955ACJL</basicUdiDi>
    <tradeName>06938695501301</tradeName>
    <deviceName>Arthroscopic Cannula</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>AC5572O</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:36.345Z</lastUpdated>
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    <udiDi>06938695501295</udiDi>
    <basicUdiDi>69386955SDLC</basicUdiDi>
    <tradeName>06938695501295</tradeName>
    <deviceName>Bone Cement Injection Gun</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>SD8101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:35.553Z</lastUpdated>
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    <udiDi>06938695501172</udiDi>
    <basicUdiDi>69386955CRKQ</basicUdiDi>
    <tradeName>06938695501172</tradeName>
    <deviceName>Curet</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG9001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:34.746Z</lastUpdated>
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    <udiDi>06938695501165</udiDi>
    <basicUdiDi>69386955BCJP</basicUdiDi>
    <tradeName>Biopsy Instrument</tradeName>
    <deviceName>Biopsy Instrument</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>BC1101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:33.954Z</lastUpdated>
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    <udiDi>06938695501073</udiDi>
    <basicUdiDi>69386955VOMB</basicUdiDi>
    <tradeName>06938695501073</tradeName>
    <deviceName>Vertebral Osteotome</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>V01103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:33.147Z</lastUpdated>
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    <udiDi>06938695500137</udiDi>
    <basicUdiDi>69386955PKPV6Q</basicUdiDi>
    <tradeName>Kyphoplasty System</tradeName>
    <deviceName>Kyphoplasty Procedure Pack</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000040949</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>FG0005-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:32.339Z</lastUpdated>
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    <udiDi>06938695501066</udiDi>
    <basicUdiDi>69386955SPLS7L</basicUdiDi>
    <tradeName>06938695501066</tradeName>
    <deviceName>Medical Balloon Catheter Syringe Pump</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017688</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>FG4203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:30.752Z</lastUpdated>
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    <udiDi>06938695500243</udiDi>
    <basicUdiDi>69386955PKPVIIAX</basicUdiDi>
    <tradeName>Kyphoplasty System</tradeName>
    <deviceName>Kyphoplasty Procedure Pack</deviceName>
    <manufacturerName>Shanghai Kinetic Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000040949</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>FG0007-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:30.061Z</lastUpdated>
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    <udiDi>06936260855477</udiDi>
    <basicUdiDi>69362608SV211-DNQ</basicUdiDi>
    <tradeName>06936260855477</tradeName>
    <deviceName>Balloon Catheter</deviceName>
    <manufacturerName>Hicren (Zhejiang) Medtech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025999</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>SV211-14D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:05:36.292Z</lastUpdated>
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    <udiDi>06936260855378</udiDi>
    <basicUdiDi>69362608SV120-004U3</basicUdiDi>
    <tradeName>06936260855378</tradeName>
    <deviceName>Bone Cement Mixing Set</deviceName>
    <manufacturerName>Hicren (Zhejiang) Medtech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025999</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>SV120-09</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:05:35.480Z</lastUpdated>
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    <udiDi>06936260855286</udiDi>
    <basicUdiDi>69362608SV120-003TZ</basicUdiDi>
    <tradeName>06936260855286</tradeName>
    <deviceName>Bone Cement Mixing Set</deviceName>
    <manufacturerName>Hicren (Zhejiang) Medtech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025999</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>SV120-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:05:34.693Z</lastUpdated>
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    <udiDi>06936260855194</udiDi>
    <basicUdiDi>69362608SV120-002TX</basicUdiDi>
    <tradeName>06936260855194</tradeName>
    <deviceName>Bone Cement Mixing Set</deviceName>
    <manufacturerName>Hicren (Zhejiang) Medtech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025999</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>SV120-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:05:33.884Z</lastUpdated>
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