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9734436

by Medtronic Navigation Inc.

Ref 9734436

9734436 is a device classified as Class I in the EU and Class II in the US made by Medtronic Navigation Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 0763000B000008178) and listed in FDA GUDID since 20 Jan 2019 (UDI-DI 00763000339227), active as of 8 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000008178 Basic UDI-DI 00763000339227UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000339227 UDI-DI Date20 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000008178 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00763000339227 listed 20 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00763000339227
  2. Registered EUDAMED 0763000B000008178

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Stereotactic surgery system probe, reusable
Device name
Tactile Probe
Model / reference
9734436
Primary DI / UDI-DI
00763000339227 EUDAMED
00763000121228 GUDID
Basic UDI-DI
0763000B000008178
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Stereotactic surgery system probe, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000339227
GUDID
00763000121228
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000339227; FDA GUDID lists 00763000121228), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Stereotactic surgery system probe, reusable

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)