<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00889024594029</udiDi>
    <basicUdiDi>889024-ZB004120-FB</basicUdiDi>
    <tradeName>ROSA PKA VALIDATION TOOL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zimmer CAS</manufacturerName>
    <manufacturerSrn>CA-MF-000000791</manufacturerSrn>
    <authorisedRepresentativeName>Biomet Global Supply Chain Center B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12130480</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-8020-034-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T01:48:21.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-880132023</udiDi>
    <basicUdiDi>B-880132023</basicUdiDi>
    <tradeName>D-880132023</tradeName>
    <deviceName>8801320 NDI Sterile Passive Spheres; 10 spheres per tray; 2 trays per box. Total 20 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>8801320x</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:29.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88010852G</udiDi>
    <basicUdiDi>B-88010852G</basicUdiDi>
    <tradeName>D-88010852G</tradeName>
    <deviceName>8801085 NDI Sterile Passive Markers - 5 spheres in tray 1 tray per box OEM 509</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>8801085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:28.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88010752D</udiDi>
    <basicUdiDi>B-88010752D</basicUdiDi>
    <tradeName>D-88010752D</tradeName>
    <deviceName>8801075 NDI Sterile Passive Markers - 5 spheres in tray 12 trays per box OEM 509</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>8801075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:27.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88010742B</udiDi>
    <basicUdiDi>B-88010742B</basicUdiDi>
    <tradeName>D-88010742B</tradeName>
    <deviceName>8801074 NDI Sterile Passive Markers - 4 spheres in tray 12 trays per box OEM 509</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>8801074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:24.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-880107125</udiDi>
    <basicUdiDi>B-880107125</basicUdiDi>
    <tradeName>D-880107125</tradeName>
    <deviceName>8801071 NDI Sterile Passive Markers - 1 sphere in tray 12 trays per box OEM 509</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>8801071</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:23.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-880105425</udiDi>
    <basicUdiDi>B-880105425</basicUdiDi>
    <tradeName>D-880105425</tradeName>
    <deviceName>8801054 NDI Sterile Passive Spheres; 4 spheres per tray; 12 trays per box. Total 48 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>8801054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:22.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-880105323</udiDi>
    <basicUdiDi>B-880105323</basicUdiDi>
    <tradeName>D-880105323</tradeName>
    <deviceName>8801053 NDI Sterile Passive Spheres; 3 spheres per tray; 12 trays per box. Total 36 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>8801053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:19.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8801051ZU</udiDi>
    <basicUdiDi>B-8801051ZU</basicUdiDi>
    <tradeName>D-8801051ZU</tradeName>
    <deviceName>8801051 NDI Sterile Passive Spheres; 1 sphere per tray; 12 trays per box. Total 12 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>8801051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:18.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8801002ZF</udiDi>
    <basicUdiDi>B-8801002ZF</basicUdiDi>
    <tradeName>D-8801002ZF</tradeName>
    <deviceName>8801002 NDI Sterile Passive Spheres; 5 spheres per tray; 12 trays per box. Total 60 spheres per</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>8801002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:17.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-880096RW</udiDi>
    <basicUdiDi>B-880096RW</basicUdiDi>
    <tradeName>D-880096RW</tradeName>
    <deviceName>8800965 NDI Sterile Passive Spheres; 9 spheres per tray; 2 trays per box. Total 18 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>8800965</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:13.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88009673L</udiDi>
    <basicUdiDi>B-88009673L</basicUdiDi>
    <tradeName>D-88009673L</tradeName>
    <deviceName>8800967 NDI Sterile Passive Spheres; 12 spheres per tray; 2 trays per box. Total 24 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>8800967</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:13.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88009663J</udiDi>
    <basicUdiDi>B-88009663J</basicUdiDi>
    <tradeName>D-88009663J</tradeName>
    <deviceName>8800966 NDI Sterile Passive Spheres; 15 spheres per tray; 2 trays per box. Total 30 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>8800966</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:13.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88007372Z</udiDi>
    <basicUdiDi>B-88007372Z</basicUdiDi>
    <tradeName>D-88007372Z</tradeName>
    <deviceName>8800737 NDI Sterile Passive Spheres; 1 sphere per pouch; 5 pouches per box. Total 5 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>8800737</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:07.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-880073833</udiDi>
    <basicUdiDi>B-880073833</basicUdiDi>
    <tradeName>D-880073833</tradeName>
    <deviceName>8800738 NDI Sterile Passive Spheres; 3 spheres per pouch; 5 pouches per box. Total 15 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>8800738</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:05.290Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>09369998142903</udiDi>
    <basicUdiDi>B-09369998142903</basicUdiDi>
    <tradeName>Navbit Sprint</tradeName>
    <deviceName>Navbit Sprint Device, Lateral Registration</deviceName>
    <manufacturerName>Navbit Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016920</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130401</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBS-00-002</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:04.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>09369998068180</udiDi>
    <basicUdiDi>B-09369998068180</basicUdiDi>
    <tradeName>Navbit Sprint</tradeName>
    <deviceName>Navbit Sprint Device, Supine Registration</deviceName>
    <manufacturerName>Navbit Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016920</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12130401</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBS-00-001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:02.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290115753431</udiDi>
    <basicUdiDi>0763000B00026468J</basicUdiDi>
    <tradeName>MAZOR X Stealth Edition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mazor Robotics Ltd.</manufacturerName>
    <manufacturerSrn>IL-PR-000014544</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130401</emdnCode>
    <emdnDescription>STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT0574</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:49:49.099Z</lastUpdated>
  </row>
</eudamedExport>