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    <tradeName>PKIT LEVO, PRONEVIEW, SG, 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>
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    <lastUpdated>2026-06-21T23:25:06.021Z</lastUpdated>
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    <tradeName>PKIT LEVO PLATFORM, 7 IN GT, SG, 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>
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    <basicUdiDi>0842430196506U</basicUdiDi>
    <tradeName>Levó Arm</tradeName>
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    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>QuickConnect Aluminum Skull Clamp Adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>QuickConnect Radiolucent DORO Adapter</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>
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    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7887-802</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:05.926Z</lastUpdated>
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    <tradeName>QuickConnect Radiolucent Mayfield Adapter</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>
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    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7887-803</reference>
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    <lastUpdated>2026-06-21T23:25:05.910Z</lastUpdated>
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    <udiDi>00842430105043</udiDi>
    <basicUdiDi>0842430196506U</basicUdiDi>
    <tradeName>Levó Control Handles</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>CONVENTIONAL REMOTE CONTROL TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7887-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:05.894Z</lastUpdated>
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    <tradeName>Levó Z Tower</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>
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    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7887-060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:05.872Z</lastUpdated>
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    <tradeName>Trios Orthopedic Trauma 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>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7855</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:05.850Z</lastUpdated>
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    <udiDi>00842430105098</udiDi>
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    <tradeName>Pivoting Arm Board w/Tempur 3in</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>5357</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:05.824Z</lastUpdated>
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    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>WILSON PLUS UNIVERSAL W/TEMPUR PADS</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>5319G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:05.804Z</lastUpdated>
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    <udiDi>00842430105111</udiDi>
    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>Inflatable Bladder (6x10in)</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>
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    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>973</reference>
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    <lastUpdated>2026-06-21T23:25:05.781Z</lastUpdated>
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    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>Inflatable Bladder (8x10in)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-21T23:25:05.763Z</lastUpdated>
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    <basicUdiDi>0842430158956Y</basicUdiDi>
    <tradeName>Side Rail Adapter 18in</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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    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7803-514</reference>
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    <tradeName>Traction Tube Clamp Assembly Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5855-673</reference>
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    <tradeName>Trios/OTS Traction Extension Short</tradeName>
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    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Trios/OTS Traction Extension Long</tradeName>
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    <tradeName>Traction Unit</tradeName>
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    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002901</manufacturerSrn>
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    <tradeName>Traction Foot Plate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mizuho Orthopedic Systems, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Soft Traction Boot Small</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>5855-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:25:05.633Z</lastUpdated>
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