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Sedecal Spl-Hf-8.0

by Sedecal., Sa.

Part of a family of 63 devices: see the family page

Ref SPL-HF-8.0Model PHOENIX, EASY MOVING, MOBIXRAY, PrimeX, SPL, DRAGON X, PEGASUS, CYCLOPS

Sedecal Spl-Hf-8.0, a portable basic diagnostic x-ray system (EU MDR Class IIb; FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Sedecal., Sa., was registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 843604600MOBILECM), cleared under FDA 510(k) K103522 on 26 Jan 2011 and listed in FDA GUDID on 28 Oct 2016 (UDI-DI 08436046001794); the registry lists it as not in commercial distribution (GUDID) as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103522

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number843604600MOBILECM Basic UDI-DI 08436046001794UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08436046001794 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK103522 Date26 Jan 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 843604600MOBILECM registered 17 Sep 2026 Active
  • FDA 510(k) K103522 decided 26 Jan 2011 Active
  • FDA GUDID UDI-DI 08436046001794 listed 28 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103522
  2. Listed FDA GUDID 08436046001794
  3. Registered EUDAMED 843604600MOBILECM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Sedecal
Generic name
Portable basic diagnostic x-ray system, analogue
Device name
Mobile - Portable X-Ray Unit
Model / reference
SPL-HF-8.0, PHOENIX, EASY MOVING, MOBIXRAY, PrimeX, SPL, DRAGON X, PEGASUS, CYCLOPS
Primary DI / UDI-DI
08436046001794
Basic UDI-DI
843604600MOBILECM
510(k) Number
FDA product code
IZL
EMDN code
Z11039016 Mobile radiographic units
GMDN term
Portable basic diagnostic x-ray system, analogue
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1720
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Portable basic diagnostic x-ray system, analogue

Cleared under the same submission (K103522)

Similar devices in this category

Other devices filed under MOBILE RADIOGRAPHIC UNITS.

Other devices from Sedecal., Sa.

See all devices from Sedecal., Sa. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)