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Robin Navigation Disposable Kit

by Orthokey Italia SRL United States EUDAMED

Ref 20201002Model Disposable Kits

EMDN T030199,Z12011485

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805267596Disposable_KitD3 Basic UDI-DIDate24 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Disposable Kits, 20201002
Primary DI / UDI-DI
08052675961317
Basic UDI-DI
805267596Disposable_KitD3
EMDN Code
T030199,Z12011485
Device Class
Class I
Medical Purpose
The procedure pack is intended to support surgical procedures performed with navigation and robotic systems by providing sterile drapes and optical tracking markers, in accordance with the intended purpose and instructions for use of the individual CE-marked devices included in the pack

Manufacturer details

EUDAMED SRN
IT-PR-000052219

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 8cbe899a-b5f2-4006-9252-1c82a1a562b1 61 fields · synced 24 Oct 2026