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S8 Clinical Application Software

by Medtronic Navigation Inc. United States EUDAMED

Ref 9735762

EMDN Z12011492

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0763000B00019918X Basic UDI-DIDate25 Sep 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

Device Name
S8 Clinical Application Software
Model / Reference
9735762
Primary DI / UDI-DI
00824846013297
Basic UDI-DI
0763000B00019918X
EMDN Code
Z12011492 Surgical navigation instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023263
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic Navigation, Inc.

See all devices from Medtronic Navigation, Inc. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 00824846013297|0763000B00019918X 61 fields · synced 24 Oct 2026