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HaGuide Software

by Alpha Omega Engineering Corp. 2 variants

Ref 407-000024-00

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011406123MERNOQ5 Basic UDI-DI 07290114064965UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290114064965 UDI-DI Date13 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000324069 Active Supplemented Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    30 Jul 2026
    Expires
    5 Apr 2028
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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

Trade Name
HaGuide Software 6.2 EUDAMED
HaGuide Software GUDID
Generic Name
Depth electrode
Device Name
Neuro Omega
Model / Ref / Catalog
407-000024-00, HaGuide Software
Primary DI / UDI-DI
07290114064965
Basic UDI-DI
729011406123MERNOQ5
510(k) Number
FDA Product Code
GZL
EMDN Code
N010199 Neurophysiology devices - other
GMDN Term
Depth electrode
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
882.1330
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
407-000024-00
GUDID
HaGuide Software
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K220553)

Other devices from Alpha Omega Engineering Corp.

See all devices from Alpha Omega Engineering Corp. →

Properties

  • Measuring Function

Other properties (23)

  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No