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Delphi-MD system

by QuantalX Neurosciense Ltd.

Ref HXM-FG-0001

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07290018971017 UDI-DI Date5 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number7290018971DELPHIMDYS Basic UDI-DI 07290018971017UDI-DIDate30 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
Delphi-MD system EUDAMED
DELPHI-MD System Device GUDID
Generic Name
Evoked-potential graphic recording system
Model / Reference
HXM-FG-0001 EUDAMED
1 GUDID
Primary DI / UDI-DI
07290018971017
Basic UDI-DI
7290018971DELPHIMDYS
Direct Marketing DI
07290018971017
De Novo Number
FDA Product Code
SFN
EMDN Code
N010199 Neurophysiology devices - other
GMDN Term
Evoked-potential graphic recording system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
HXM-FG-0001
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IL-MF-000022045
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from QuantalX Neurosciense Ltd.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • 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
  • Measuring Function: 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
  • Expiration Date: No