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    <tradeName>ProAxis Rail Mount Left</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-899</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.873Z</lastUpdated>
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    <tradeName>ProAxis Rail Mount Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
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    <udiDi>00842430106927</udiDi>
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    <tradeName>ProAxis/Insite Arm Board Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <reference>6988-526</reference>
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    <tradeName>ProAxis Chest Pad</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-758</reference>
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    <lastUpdated>2026-06-21T23:25:03.820Z</lastUpdated>
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    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>ProAxis Cervical Traction Vector Long</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-725</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.801Z</lastUpdated>
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    <udiDi>00842430106965</udiDi>
    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>ProAxis Cervical Mgmt Mounting Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.784Z</lastUpdated>
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    <udiDi>00842430106972</udiDi>
    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>LEG SUPPORT TRAY ASSY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6844-148</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.766Z</lastUpdated>
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    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>Buttocks Strap w/Velcro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6977-739</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.750Z</lastUpdated>
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    <tradeName>ProAxis Head-End Supine Top</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-623</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.736Z</lastUpdated>
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    <udiDi>00842430107030</udiDi>
    <basicUdiDi>0842430196506U</basicUdiDi>
    <tradeName>HANA FEMUR LIFT FOOT PEDAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6875-5005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.724Z</lastUpdated>
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    <udiDi>00842430107047</udiDi>
    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>ProAxis Foot-End Supine Top</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-621</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.713Z</lastUpdated>
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    <udiDi>00842430107054</udiDi>
    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>PKIT PROAXIS LPV SG HIP ARM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988A-PV-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.700Z</lastUpdated>
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    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>PKIT, GT, PROAXIS, 1/EA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988A-GT-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.678Z</lastUpdated>
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    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>RETRACTER ADAPTER, RADIOLUCENT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-449</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.657Z</lastUpdated>
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    <tradeName>ProAxis Cervical Traction Vector Short</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6988-720</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.635Z</lastUpdated>
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    <tradeName>COMBO HIP/THIGH PAD, LEFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
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    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5939-L</reference>
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    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
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    <tradeName>Articulating Arm Board Assembly</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5579-60</reference>
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    <tradeName>Trios/STS Articulating Arm Board Bracket</tradeName>
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    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5579-90</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>ARM BOARD STRAP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5840-42</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:03.511Z</lastUpdated>
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