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<eudamedExport entity="devices">
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    <udiDi>D-41813GJ</udiDi>
    <basicUdiDi>B-41813GJ</basicUdiDi>
    <tradeName>D-41813GJ</tradeName>
    <deviceName>41813 Disposable Reflective Marker Spheres; 2 spheres per tray; 30 trays per box. Total 60 spheres per box</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41813</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:16:46.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-41773GX</udiDi>
    <basicUdiDi>B-41773GX</basicUdiDi>
    <tradeName>Disposable Reflective Marker Spheres</tradeName>
    <deviceName>41773 Disposable Reflective Marker Spheres; 3 spheres per tray; 30 trays per box. Total 90 spheres per box</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41773</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:28.160Z</lastUpdated>
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  <row>
    <udiDi>03701311500391</udiDi>
    <basicUdiDi>B-03701311500391</basicUdiDi>
    <tradeName>03701311500391</tradeName>
    <deviceName>3D OFFSET IMAGING SET SPX1</deviceName>
    <manufacturerName>ECENTIAL ROBOTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000003577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00038</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:59:21.178Z</lastUpdated>
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  <row>
    <udiDi>03701311500070</udiDi>
    <basicUdiDi>B-03701311500070</basicUdiDi>
    <tradeName>03701311500070</tradeName>
    <deviceName>Navigation Set SPX1, Targeting Needle Bevel Tip – 11G, 125mm</deviceName>
    <manufacturerName>ECENTIAL ROBOTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000003577</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00019</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:59:20.394Z</lastUpdated>
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  <row>
    <udiDi>08800043850158</udiDi>
    <basicUdiDi>88000438CJDUY</basicUdiDi>
    <tradeName>Schanz Screw (Ø5)</tradeName>
    <deviceName>Surgical Invasive Instruments for CUVIS-joint / Schanz Screw</deviceName>
    <manufacturerName>CUREXO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000014563</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-30121-000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:29.156Z</lastUpdated>
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  <row>
    <udiDi>08800043850042</udiDi>
    <basicUdiDi>88000438CJBUU</basicUdiDi>
    <tradeName>6.2mm cutter</tradeName>
    <deviceName>Surgical Invasive Instruments for CUVIS-joint / Cutter</deviceName>
    <manufacturerName>CUREXO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000014563</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-30150-000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:25.159Z</lastUpdated>
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  <row>
    <udiDi>00805832020017</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName>Passive Reflective Markers</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:00:37.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>00805832010018</udiDi>
    <basicUdiDi>805832DRMSM3</basicUdiDi>
    <tradeName>Disposable Reflective Marker Sphere™</tradeName>
    <deviceName>Disposable Reflective Marker Spheres</deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41773</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:00:36.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00805832020024</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801053</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:33:50.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>00805832020031</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:33:27.803Z</lastUpdated>
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  <row>
    <udiDi>00805832020048</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:53.367Z</lastUpdated>
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    <udiDi>00805832030016</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800965</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:05.856Z</lastUpdated>
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    <udiDi>00805832030023</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800967</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:04.656Z</lastUpdated>
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    <udiDi>00805832030030</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800966</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:04.333Z</lastUpdated>
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    <udiDi>00805832030047</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8801320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:03.909Z</lastUpdated>
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    <udiDi>00805832040015</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800737</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:01.129Z</lastUpdated>
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    <udiDi>00805832040022</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800738</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:01.062Z</lastUpdated>
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    <udiDi>00805832040039</udiDi>
    <basicUdiDi>805832PassiveJ5</basicUdiDi>
    <tradeName>Passive Spheres™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Northern Digital Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023503</manufacturerSrn>
    <authorisedRepresentativeName>NDI Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000019156</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800739</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:01.028Z</lastUpdated>
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    <udiDi>10603295519096</udiDi>
    <basicUdiDi>0603295a002899A</basicUdiDi>
    <tradeName>VELYS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DePuy Ireland UC</manufacturerName>
    <manufacturerSrn>IE-MF-000007377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4515-70-005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:40:05.003Z</lastUpdated>
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    <udiDi>10603295519102</udiDi>
    <basicUdiDi>0603295a002899A</basicUdiDi>
    <tradeName>VELYS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DePuy Ireland UC</manufacturerName>
    <manufacturerSrn>IE-MF-000007377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130485</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4515-70-006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:40:04.979Z</lastUpdated>
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