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Sedecal Sm-IV

by Sedecal., Sa. 3 variants

Part of a family of 11 devices: see the family page

Ref SM-IVModel SM-IV, SM-V, SPSB, SPB

Sedecal Sm-IV (CB40) is a mobile basic diagnostic x-ray system (EU MDR Class IIb; FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Sedecal., Sa., registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 843604600MOBILEGENCG), cleared under FDA 510(k) K232185 on 21 Aug 2023 and listed in FDA GUDID since 19 Sep 2023 (UDI-DI 08436046003286), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232185

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number843604600MOBILEGENCG Basic UDI-DI 08436046003286UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08436046003286 UDI-DI Date19 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK232185 Date21 Aug 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 843604600MOBILEGENCG registered 10 Sep 2026 Active
  • FDA 510(k) K232185 decided 21 Aug 2023 Active
  • FDA GUDID UDI-DI 08436046003286 listed 19 Sep 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232185
  2. Listed FDA GUDID 08436046003286
  3. Registered EUDAMED 843604600MOBILEGENCG

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  • Withdrawn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
Mobile basic diagnostic x-ray system, analogue
Device name
Mobile X-Ray Generator
Model / Ref / Catalog
SM-IV, SM-V, SPSB, SPB, CB40
Primary DI / UDI-DI
08436046003286
Basic UDI-DI
843604600MOBILEGENCG
510(k) Number
FDA product code
IZL
EMDN code
Z11039016 Mobile radiographic units
GMDN term
Mobile 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
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: Mobile basic diagnostic x-ray system, analogue

Cleared under the same submission (K232185)

Similar devices

Also classified as Mobile basic diagnostic x-ray system, analogue.

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)