EDITOR HFe 401

by Spellman High Voltage Electronics Corp. 12 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberESPN091230104S0 UDI-DI	Date13 Jun 2018Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: EDITOR HFe
Generic Name: Diagnostic x-ray system generator, stationary
Model / Ref / Catalog: 401, 091230104-S
Description: EDITOR HFe401 0,55m 1P SHV US

Primary DI / UDI-DI: ESPN091230104S0
FDA Product Code: IZO
GMDN Term: Diagnostic x-ray system generator, stationary

Device Class: Class I
Regulation Number: 892.1700
GUDID distribution status: In Commercial Distribution

Other devices from Spellman High Voltage Electronics Corp.

EDITOR HFe 801

Class I
EDITOR HFe 401

Class I
EDITOR HFe 501

Class I
EDITOR HFe 601

Class I
EDITOR HFe 501

Class I
EDITOR HFe 501

Class I

See all devices from Spellman High Voltage Electronics Corp. →

Properties

Prescription Use
Premarket Exempt
Serial Number
Manufacturing Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Expiration Date: No