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Sedecal SPSL8HC

by Sedecal., Sa.

Sedecal SPSL8HC is a Class II device made by Sedecal., Sa., listed in FDA GUDID since 15 Feb 2018 (UDI-DI 08436046001893), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08436046001893 UDI-DI Date15 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sedecal
Generic name
Portable basic diagnostic x-ray system, digital
Model / reference
SPSL8HC
Primary DI / UDI-DI
08436046001893
FDA product code
MQB, IZL
GMDN term
Portable basic diagnostic x-ray system, digital
Device class
Class II
Regulation number
892.1680, 892.1720
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Other devices from Sedecal., Sa.

See all devices from Sedecal., Sa. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)