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    <tradeName>X-Twist 4.75mm tap, DEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parcus Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010639</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XT04703</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:38.245Z</lastUpdated>
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    <udiDi>00816342025522</udiDi>
    <basicUdiDi>081634202TD00BWM</basicUdiDi>
    <tradeName>X-Twist 3.6mm awl for 4.75mm X-Twist</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parcus Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010639</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XT04702</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:38.127Z</lastUpdated>
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    <udiDi>00816342025713</udiDi>
    <basicUdiDi>081634202TD00BWM</basicUdiDi>
    <tradeName>X-Twist 5.5mm tap, DEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parcus Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010639</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XT05501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:38.080Z</lastUpdated>
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    <udiDi>00816342025430</udiDi>
    <basicUdiDi>081634202TD00BWM</basicUdiDi>
    <tradeName>X-Twist 5.5 Tap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parcus Medical, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000010639</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XT05500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:37.997Z</lastUpdated>
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    <udiDi>08680745004758</udiDi>
    <basicUdiDi>8680745DLCJV</basicUdiDi>
    <tradeName>HUDSON Delici Uç 14 mm</tradeName>
    <deviceName>KEMİK DELİCİLER</deviceName>
    <manufacturerName>KARBON MEDİKAL SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA 5092</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:33:23.828Z</lastUpdated>
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    <udiDi>08809595975609</udiDi>
    <basicUdiDi>B-08809595975609</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMA-4518-AWL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:16:50.083Z</lastUpdated>
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    <udiDi>08809595975593</udiDi>
    <basicUdiDi>B-08809595975593</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLA-4750-PUNCH</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:16:49.295Z</lastUpdated>
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    <udiDi>08809595975616</udiDi>
    <basicUdiDi>B-08809595975616</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMA-5519-AWL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:16:48.478Z</lastUpdated>
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    <udiDi>08809399748560</udiDi>
    <basicUdiDi>B-08809399748560</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHA-4820-AWL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:49:37.297Z</lastUpdated>
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    <udiDi>08809399746269</udiDi>
    <basicUdiDi>B-08809399746269</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-092</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:38.351Z</lastUpdated>
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    <udiDi>08800071020950</udiDi>
    <basicUdiDi>B-08800071020950</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIS-2610-DR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:01:16.437Z</lastUpdated>
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    <udiDi>08800071020943</udiDi>
    <basicUdiDi>B-08800071020943</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIS-2110-DR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:01:15.636Z</lastUpdated>
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    <udiDi>08800071019763</udiDi>
    <basicUdiDi>B-08800071019763</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110045297</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:01:10.034Z</lastUpdated>
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    <udiDi>08800071019756</udiDi>
    <basicUdiDi>B-08800071019756</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110045296</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:01:09.232Z</lastUpdated>
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    <udiDi>08800071019572</udiDi>
    <basicUdiDi>B-08800071019572</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110045278</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:01:05.249Z</lastUpdated>
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    <udiDi>08800071019558</udiDi>
    <basicUdiDi>B-08800071019558</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110045276</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:01:02.853Z</lastUpdated>
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    <udiDi>08800071019534</udiDi>
    <basicUdiDi>B-08800071019534</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110045274</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:00:58.820Z</lastUpdated>
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    <udiDi>08800071019404</udiDi>
    <basicUdiDi>B-08800071019404</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110045261</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:00:56.432Z</lastUpdated>
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    <udiDi>03701313002350</udiDi>
    <basicUdiDi>B-03701313002350</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Pointe carrée courte</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01AS1010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:07:44.240Z</lastUpdated>
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    <udiDi>03701313001315</udiDi>
    <basicUdiDi>B-03701313001315</basicUdiDi>
    <tradeName>KHEIRON</tradeName>
    <deviceName>Pointe Carrée Courte</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0927</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24SA1015</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T17:02:51.934Z</lastUpdated>
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