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X-Guide

by X-Nav Technologies, LLC 2 variants

Ref P011000

X-Guide (P011000) is a surgical planning/navigation-enhancement system (EU MDD Class IIa; FDA Class II) made by X-Nav Technologies, LLC, registered in EUDAMED on 18 Nov 2021 (Basic UDI-DI B-00817421021794) and listed in FDA GUDID since 3 Sep 2021 (UDI-DI 00817421021794), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817421021794 Basic UDI-DI 00817421021794UDI-DIDate18 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00817421021794 UDI-DI Date3 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00817421021794 registered 18 Nov 2021 Active
  • FDA GUDID UDI-DI 00817421021794 listed 3 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817421021794
  2. Registered EUDAMED B-00817421021794

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Surgical planning/navigation-enhancement system
Device name
X-Guide Surgical Navigation System
Model / reference
P011000
Primary DI / UDI-DI
00817421021794 EUDAMED
00817421021787 GUDID
Basic UDI-DI
B-00817421021794
FDA product code
PLV, QRY
EMDN code
Z12011401 Surgical navigation system
GMDN term
Surgical planning/navigation-enhancement system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.4120
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00817421021794
GUDID
00817421021787
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00817421021794; FDA GUDID lists 00817421021787), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000003234
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from X-Nav Technologies, LLC

  • X-Guide P011265

    Class II

  • X-Guide P011266

    Class II

  • X-Guide P011268

    Class II

  • X-Guide P011271

    Class II

See all devices from X-Nav Technologies, LLC →

Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)