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    <deviceName>Metal Suture Anchor</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
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    <deviceName>Metal Suture Anchor</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
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    <deviceName>Washer for Cannulated Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>CANCELLOUS SCREWS</emdnDescription>
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    <deviceName>Metal Suture Anchor</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>ANCHORS, TENDON AND LIGAMENT SYNTHESIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:56:05.029Z</lastUpdated>
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    <basicUdiDi>B-06941919231038</basicUdiDi>
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    <deviceName>Metal Suture Anchor</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120102</emdnCode>
    <emdnDescription>ANCHORS, TENDON AND LIGAMENT SYNTHESIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153750280S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:55:47.239Z</lastUpdated>
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    <deviceName>Metal Suture Anchor</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>ANCHORS, TENDON AND LIGAMENT SYNTHESIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153750200S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:55:46.441Z</lastUpdated>
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    <basicUdiDi>B-06941919200010</basicUdiDi>
    <tradeName>06941919200010</tradeName>
    <deviceName>PEEK Suture Anchor</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120102</emdnCode>
    <emdnDescription>ANCHORS, TENDON AND LIGAMENT SYNTHESIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151490550S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:55:45.639Z</lastUpdated>
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    <deviceName>PEEK Suture Anchor</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120102</emdnCode>
    <emdnDescription>ANCHORS, TENDON AND LIGAMENT SYNTHESIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151490450S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:55:44.043Z</lastUpdated>
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    <tradeName>06941909442604</tradeName>
    <deviceName>PEEK Interference Screw</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152151028S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:55:40.042Z</lastUpdated>
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    <udiDi>06941909442598</udiDi>
    <basicUdiDi>B-06941909442598</basicUdiDi>
    <tradeName>06941909442598</tradeName>
    <deviceName>PEEK Interference Screw</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153571023S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:55:39.250Z</lastUpdated>
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    <udiDi>06941709479305</udiDi>
    <basicUdiDi>B-06941709479305</basicUdiDi>
    <tradeName>06941709479305</tradeName>
    <deviceName>End Cap</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T40820804YN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:28:24.778Z</lastUpdated>
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    <udiDi>06941709478032</udiDi>
    <basicUdiDi>B-06941709478032</basicUdiDi>
    <tradeName>06941709478032</tradeName>
    <deviceName>NAVIGATORTM 5.0mm Condylar Nut</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T40855013YN</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T12:28:23.979Z</lastUpdated>
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    <udiDi>06932172516734</udiDi>
    <basicUdiDi>B-06932172516734</basicUdiDi>
    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000582</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:45.271Z</lastUpdated>
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    <udiDi>06932172516727</udiDi>
    <basicUdiDi>B-06932172516727</basicUdiDi>
    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000581</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:44.468Z</lastUpdated>
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    <udiDi>06932172516710</udiDi>
    <basicUdiDi>B-06932172516710</basicUdiDi>
    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000580</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:43.670Z</lastUpdated>
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    <udiDi>06932172512859</udiDi>
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    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000579</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:39.659Z</lastUpdated>
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    <udiDi>06932172512842</udiDi>
    <basicUdiDi>B-06932172512842</basicUdiDi>
    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000578</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:38.864Z</lastUpdated>
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    <udiDi>06932172512835</udiDi>
    <basicUdiDi>B-06932172512835</basicUdiDi>
    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000577</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:38.066Z</lastUpdated>
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    <basicUdiDi>B-06932172512828</basicUdiDi>
    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000576</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:37.273Z</lastUpdated>
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    <basicUdiDi>B-06932172512811</basicUdiDi>
    <tradeName>iKey</tradeName>
    <deviceName>Bone Screws</deviceName>
    <manufacturerName>Beijing iKey Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008526</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000575</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:04:33.262Z</lastUpdated>
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