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    <tradeName>2.4mm Volar Distal Radius Instrument Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>922 (AR-8924VIN-DS)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.179Z</lastUpdated>
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    <udiDi>00857676008188</udiDi>
    <basicUdiDi>0857676008RA958674</basicUdiDi>
    <tradeName>2.4mm Volar Distal Radius Trial Plates</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>926 (AR-8924VT-S)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.162Z</lastUpdated>
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    <udiDi>00857676008195</udiDi>
    <basicUdiDi>0857676008RA958674</basicUdiDi>
    <tradeName>2.4mm Volar Distal Radius Removal Driver</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925 (AR-8924VD-S)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.147Z</lastUpdated>
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    <udiDi>00857676008225</udiDi>
    <basicUdiDi>0857676008RA958572</basicUdiDi>
    <tradeName>VariAX 2 Xpress Distal Radius Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>991065S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.130Z</lastUpdated>
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    <udiDi>00857676008270</udiDi>
    <basicUdiDi>0857676008RA958776</basicUdiDi>
    <tradeName>TruTORQ Large Engine Adaptor, 7 Nm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.110Z</lastUpdated>
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    <udiDi>00857676008287</udiDi>
    <basicUdiDi>0857676008RA958776</basicUdiDi>
    <tradeName>TruTORQ Large Engine Adaptor, 12 Nm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.094Z</lastUpdated>
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    <udiDi>00857676008294</udiDi>
    <basicUdiDi>0857676008RA958776</basicUdiDi>
    <tradeName>TruTORQ Large Engine Adaptor, 14 Nm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.077Z</lastUpdated>
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    <udiDi>00857676008317</udiDi>
    <basicUdiDi>0857676008RA958776</basicUdiDi>
    <tradeName>TruTORQ Small Engine, 0.5-2.0 Nm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.058Z</lastUpdated>
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    <udiDi>00857676008348</udiDi>
    <basicUdiDi>0857676008RA958878</basicUdiDi>
    <tradeName>TruPWR Torque Limiting Attachment Sterile, Single-Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>228-TXRX-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.035Z</lastUpdated>
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    <udiDi>00857676008355</udiDi>
    <basicUdiDi>0857676008RA958878</basicUdiDi>
    <tradeName>TruPWR Torque Limiting Attachment Sterile, Single Use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ECA MEDICAL INSTRUMENTS</manufacturerName>
    <manufacturerSrn>US-MF-000010686</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>228-TXRX-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:12.012Z</lastUpdated>
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