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X-Guide System

by X-Nav Technologies, LLC 2 variants

Ref P011000

X-Guide System (P011000) is a medical device (EU MDR Class IIa; EMDN category surgical navigation system) made by X-Nav Technologies, LLC, registered in EUDAMED on 18 Jul 2024 (Basic UDI-DI 081742102XGUIDESNSF5), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081742102XGUIDESNSF5 Basic UDI-DI 00817421022845UDI-DIDate18 Jul 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
X-Guide Surgical Navigation System
Model / reference
P011000
Primary DI / UDI-DI
00817421022845
Basic UDI-DI
081742102XGUIDESNSF5
Direct marketing DI
00817421022845
EMDN code
Z12011401 Surgical navigation system
Device class
Class IIa
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands

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

  • Sterilise before use
Other properties (13, all answered No)