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EDITOR HFe 401

by Spellman High Voltage Electronics Corp. 2 variants

Ref 082400104

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

CE MDR

Valid until

Not listed

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

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
European UnionCE/MDR EUDAMED Number++ESPNEDITORHFe23 Basic UDI-DI ESPN0824001040UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberESPN0824001040 UDI-DI Date12 Feb 2021ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
EDITOR HFe 401 EUDAMED
EDITOR HFe GUDID
Generic Name
Diagnostic x-ray system generator, stationary
Model / Ref / Catalog
082400104, 401
Primary DI / UDI-DI
ESPN0824001040
Basic UDI-DI
++ESPNEDITORHFe23
FDA Product Code
IZO
EMDN Code
Z11039011 High voltage x-ray generators
GMDN Term
Diagnostic x-ray system generator, stationary
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
892.1700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
082400104
GUDID
401
Device ClassEUDAMED
Class IIb
GUDID
Class I

Other devices from Spellman High Voltage Electronics Corp.

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Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No