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    <tradeName>BIO-GEN®</tradeName>
    <deviceName>BIO-GEN® Cancellous cortical mix gel</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM-GEL1s</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:30.346Z</lastUpdated>
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    <udiDi>D-805651850253844</udiDi>
    <basicUdiDi>B-805651850253844</basicUdiDi>
    <tradeName>BIO-GEN®</tradeName>
    <deviceName>BIO-GEN® Cancellous cortical mix gel</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM-GEL1n</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:29.544Z</lastUpdated>
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    <udiDi>D-80565185025213K</udiDi>
    <basicUdiDi>B-80565185025213K</basicUdiDi>
    <tradeName>BIO-GEN®</tradeName>
    <deviceName>BIO-GEN® Cancellous cortical mix gel</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM-GEL05s</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:28.743Z</lastUpdated>
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    <udiDi>D-80565185025143N</udiDi>
    <basicUdiDi>B-80565185025143N</basicUdiDi>
    <tradeName>BIO-GEN®</tradeName>
    <deviceName>BIO-GEN® Cancellous cortical mix gel</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM-GEL05n</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:27.944Z</lastUpdated>
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    <udiDi>D-80565185025073R</udiDi>
    <basicUdiDi>B-80565185025073R</basicUdiDi>
    <tradeName>BIO-GEN®</tradeName>
    <deviceName>BIO-GEN® Cancellous cortical mix gel</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM-GEL02n</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:23.948Z</lastUpdated>
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    <udiDi>D-80565185024153K</udiDi>
    <basicUdiDi>B-80565185024153K</basicUdiDi>
    <tradeName>BIOCOLLAGEN® Crunch</tradeName>
    <deviceName>BIOCOLLAGEN® Crunch Mouldable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCG-CRU5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:23.139Z</lastUpdated>
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    <udiDi>D-80565185024083N</udiDi>
    <basicUdiDi>B-80565185024083N</basicUdiDi>
    <tradeName>BIOCOLLAGEN® Crunch</tradeName>
    <deviceName>BIOCOLLAGEN® Crunch Mouldable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCG-CRU10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:22.454Z</lastUpdated>
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    <udiDi>D-80565185022863Y</udiDi>
    <basicUdiDi>B-80565185022863Y</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® Collagen granules dry paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-PTY050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:20.735Z</lastUpdated>
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    <udiDi>D-805651850227943</udiDi>
    <basicUdiDi>B-805651850227943</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® Collagen granules dry paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-PTY030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:16.732Z</lastUpdated>
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    <udiDi>D-80565185022623J</udiDi>
    <basicUdiDi>B-80565185022623J</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® Collagen granules dry paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-PTY020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:15.932Z</lastUpdated>
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    <udiDi>D-80565185022553M</udiDi>
    <basicUdiDi>B-80565185022553M</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® Collagen granules dry paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-PTY010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:15.127Z</lastUpdated>
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    <udiDi>D-80565185022483Q</udiDi>
    <basicUdiDi>B-80565185022483Q</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® Collagen granules dry paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-PTY005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:14.334Z</lastUpdated>
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    <udiDi>D-805651850223137</udiDi>
    <basicUdiDi>B-805651850223137</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM mouldable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-MLD100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:10.348Z</lastUpdated>
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    <udiDi>D-80565185022243A</udiDi>
    <basicUdiDi>B-80565185022243A</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM mouldable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-MLD050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:09.533Z</lastUpdated>
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    <udiDi>D-80565185022173D</udiDi>
    <basicUdiDi>B-80565185022173D</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM mouldable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-MLD020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:08.735Z</lastUpdated>
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    <udiDi>D-80565185022002U</udiDi>
    <basicUdiDi>B-80565185022002U</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM mouldable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-MLD010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:07.947Z</lastUpdated>
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    <udiDi>D-80565185021943S</udiDi>
    <basicUdiDi>B-80565185021943S</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM mouldable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-MLD005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:03.931Z</lastUpdated>
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    <udiDi>D-80565185021873V</udiDi>
    <basicUdiDi>B-80565185021873V</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM injectable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-INJ100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:03.140Z</lastUpdated>
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    <udiDi>D-80565185021703C</udiDi>
    <basicUdiDi>B-80565185021703C</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM injectable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-INJ050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:02.331Z</lastUpdated>
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    <udiDi>D-80565185021633F</udiDi>
    <basicUdiDi>B-80565185021633F</basicUdiDi>
    <tradeName>ACTIVABONE®</tradeName>
    <deviceName>ACTIVABONE® DBM injectable paste</deviceName>
    <manufacturerName>BIOTECK S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000011484</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900401</emdnCode>
    <emdnDescription>BONE AND TENDON REPLACEMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACT-INJ020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:39:01.525Z</lastUpdated>
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